Garbin Evo, Linde LD2110X23BRecalls & reported problems

Summary

The FDA's MAUDE database contains 158 adverse event reports that list this exact device (DI 00606959057432), received between Jul 22, 2022 and Jun 29, 2026 — classified as 158 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (99 reports).

3 FDA recall records name this device's identifier, 3 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Oct 7, 2024Class IOpen, Classified

   Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.

   Z-0295-2025 · Root cause: Device Design · Recall details · FDA record ↗

2. Jul 16, 2024Class IOpen, Classified

   Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.

   Z-2944-2024 · Root cause: Device Design · Recall details · FDA record ↗

3. Mar 19, 2024Class IOpen, Classified

   Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

   Z-1500-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 158 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE ERROR CODE WAS FOUND DURING MAINTENANCE REQUIRED ON A GARBIN EVO DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE GARBIN EVO DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE, THERAPY HELD IN BOOT MONITORING, WAS OBSERVED ON THE DEVICE'S ALARM LOG. THE THIRD-PARTY SERVICE TECHNICIAN FURTHER EVALUATED AND DETERMINED THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) HAD CAUSED THE VENTILATOR INOPERATIVE ERROR CODE TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S SYSTEM PCA NEEDS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE DISPLAY PCA NEEDS REPLACED DUE TO THE ERROR LOG WAS UNRETRIEVABLE PRIOR TO FINDING THE ERROR CODE. THIS WAS UNRELATED TO THE REPORTABLE ISSUE. THE BATTERIES (INTERNAL AND DETACHABLE) NEEDS REPLACED FOR THESE TWO PARTS HAD FAILED, WHICH WAS UNRELATED TO THE REPORTABLE ISSUE. THE AIR FOAM INLET FILTER AND PARTICULATE FILTER NEED REPLACED FOR PREVENTATIVE MAINTENANCE UNRELATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25658292 ↗
• MalfunctionJun 29, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY EVO VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION AND PREVENTATIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. ON EVALUATION, VENTILATOR SERVICE REQUIRED ALARM E-384 INDICATING THE DEVICE SOFTWARE HAS DETECTED A LARGE PRESSURE DROP BETWEEN THE MONITOR AND OUTLET PRESSURE SENSORS (I.E. ACROSS THE MACHINE FLOW SENSOR). THE MACHINE FLOW SENSOR WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: THE SYSTEM PRINTED CIRCUIT BOARD ASSEMBLY WAS REPLACED DUE TO TRANSIENT SENSOR EVENTS. THIS DEVICE BEEN SERVICED, INSPECTED, TESTED, MET ACCEPTANCE CRITERIA IN ACCORDANCE WITH ALL THE APPLICABLE CUSTOMER REQUIREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25650698 ↗
• MalfunctionJun 29, 2026Display or Visual Feedback Problem; Electrical /Electronic Property Problem

  THE GARBIN EVO VENTILATOR WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR REQUIRED MAINTENANCE. THE DEVICE WAS NOT REPORTED TO BE IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE IN-PROCESS EVALUATION IT WAS NOTED THAT THE SYSTEM BOARD AND DISPLAY BOARD ARE DEFECTIVE AND NEEDS TO BE REPLACED. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE THE AIR FOAM INLET FILTER AND PARTICULATE FILTER WILL BE REPLACED DUE TO PREVENTATIVE MAINTENANCE. THE PROXIMAL FILTERS AND MACHINE FLOW SENSOR ARE CONTAMINATED; AND NEEDS TO BE REPLACED. THE EVALUATION IS STILL IN PROCESS AND PENDING THE REPAIR APPROVAL BY THE CUSTOMER. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25650012 ↗
• MalfunctionJun 23, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY EVO VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR COMPLETION OF PREVENTATIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. ON EVALUATION, A CRITICAL DEVICE ERROR CODE E-386 WAS NOTED IN THE ERROR LOG INDICATING MACHINE FLOW SENSOR OFFSET GREATER THAN 0.2 SLPM. THE MACHINE FLOW SENSOR REQUIRED REPLACEMENT TO ADDRESS THIS ISSUE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: THE SYSTEM PRINTED CIRCUIT BOARD ASSEMBLY REQUIRED REPLACEMENT AND INTERIOR COMPONENTS WERE NOTED TO BE CONTAMINATED WITH DUST. PREVENTATIVE MAINTENANCE WITH REQUIRED COMPONENT REPLACEMENTS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25592721 ↗
• MalfunctionJun 18, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT THE TRILOGY EVO VENTILATOR WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR COMPLETION OF PREVENTATIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. ON DEVICE EVALUATION, VENTILATOR INOPERATIVE ERROR CODE E-155 WAS NOTED IN THE ERROR LOG INDICATING THE MACHINE FLOW SENSOR DRIFT ABOVE WAS THE SPECIFICATION. THE MACHINE FLOW SENSOR REQUIRES REPLACEMENT TO ADDRESS THIS ISSUE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: BASED ON DEVICE EVENT CODE E-144 INDICATING THE MOTOR CONTROLLER HAS PROCEEDED TO THE SHUTDOWN STATE DUE TO AN ERROR WITH THE MOTOR, THE BLOWER ASSEMBLY REQUIRES REPLACEMENT. DUE TO EVENT CODE E-330 INDICATING SENSOR OFFSET DURING DRIFT CALCULATION IS TOO HIGH, THE SYSTEM PRINTED CIRCUIT BOARD ASSEMBLY REQUIRES REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25545616 ↗
• MalfunctionJun 5, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION INDICATING THAT DURING A SOFTWARE UPDATE ON A TRILOGY EVO DEVICE (UPGRADING FROM VERSION 1.06.10.00 TO 1.06.15.00) DISPLAYED A "VENT INOPERATIVE" MESSAGE AND ENCOUNTERED ERROR E008 (EVT_ARM_MEM_FAULT_EXCEPTION). THIS ERROR OCCURS WHEN THE DEVICE REBOOTS THREE TIMES WITHIN A 24-HOUR PERIOD, RESULTING IN A "VENT INOPERATIVE" STATE. IT IS IMPORTANT TO NOTE THAT THIS ISSUE OCCURRED DURING THE SOFTWARE UPDATE. THE DEVICE WAS NOT IN PATIENT USE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THE DEVICE LOGS WERE EVALUATED, AND ERROR CODE E046 VENT SERVICE REQUIRED ALARM (EVT_INTERNAL_BATT_NOT_DETECTED) AND E305 VENT SERVICE REQUIRED ALARM TOUCH SCREEN UNRESPONSIVE (EVT_TOUCHSCREEN_FAIL) WERE DISCOVERED. DUE TO THE ERRORS, THE PRINTED CIRCUIT ASSEMBLY (PCA) WAS REPLACED. ADDITIONALLY, NO OTHER PROBLEMS APPEARED AFTER REPLACING THE SYSTEM PCA. THE PARTICULATE FILTER AND AIR INLET FOAM FILTER WILL NEED TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25411478 ↗
• MalfunctionMay 28, 2026Device Sensing Problem

  A TRILOGY EVO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR PREVENTIVE MAINTENANCE. NO MEDICAL INTERVENTION WAS SPECIFIED. THE DEVICE WAS NOT REPORTED TO BE IN CLINICAL USE. DURING THE EVALUATION OF THE TRILOGY EVO DEVICE AT THE THIRD-PARTY SERVICE CENTER, IT WAS NOTED THAT AN ERROR CODE RELATED TO A PRESSURE MISMATCH WAS FOUND DUE TO HEAVY CONTAMINATION. IN CONCLUSION, THE DEVICE'S FLOW SENSOR NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS RETURNED UNREPAIRED PER THE CUSTOMER'S REQUEST. SHOULD FURTHER INVESTIGATION PROVIDE NEW INFORMATION THAT IMPACTS THE OUTCOME OF THE INVESTIGATION OR THE ASSOCIATED MEDICAL DEVICE REPORTING, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25311872 ↗
• MalfunctionMay 26, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING TWO VENTILATION INOP AND A VENTILATOR SERVICE REQUIRED ERROR CODES WERE FOUND DURING PREVENTATIVE MAINTENANCE ON A GARBIN EVO DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION IT WAS NOTED THAT TWO VENTILATOR INOPERATIVE CODES, MACHINE FLOW RAILED LOW AND MACHINE FLOW STUCK, AND A VENTILATOR SERVICE REQUIRED, PRESSURE SENSOR MISMATCH, ERROR CODES WERE OBSERVED ON THE DEVICE'S ERROR LOG. THE DEVICE EVALUATION DOES NOT IDENTIFY ANY SPECIFIC COMPONENT MALFUNCTION THAT WOULD NEED TO BE REPLACED TO RESOLVE THE VENTILATOR INOPERATIVE AND VENTILATION SERVICE REQUIRED CONDITIONS. THE WERE NO REPAIRS AND/OR PARTS REPLACED TO ADDRESS THESE ERROR CODES FOUND ON THIS DEVICE; THEREFORE, NO ADDITIONAL REPAIR INFORMATION WAS PROVIDED. THE ROOT CAUSE ISN'T CONFIRMED AT THIS TIME. A FINAL REPORT IS BEING SUBMITTED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE SYSTEM PRINTED CIRCUIT ASSEMBLY WAS REPLACED TO ADDRESS ANOTHER ERROR CODE, PRESS PAIR ERROR, THAT WAS OBSERVED ON THE DEVICE'S ERROR LOG. THIS WAS UNRELATED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25276777 ↗
• MalfunctionMay 21, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  A TRILOGY EVO WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR PREVENTIVE MAINTENANCE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION A VENTILATOR INOPERATIVE ALARM INDICATING A MACHINE FLOW DRIFT WAS OBSERVED IN THE DOWNLOADED EVENT LOG. THE DEVICE'S MACHINE FLOW SENSOR WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, NOT RELATED TO THE REPORTABLE ISSUE, A MOTOR CONTROLLER SHUTDOWN ALARM WAS OBSERVED. THE DEVICE'S BLOWER ASSEMBLY WAS REPLACED TO ADDRESS THE ISSUES. THIS ISSUE WOULD NOT AFFECT THE DEVICE'S ABILITY TO DELIVER THERAPY AS DESIGNED. THE DEVICE WAS TESTED AND PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25244505 ↗
• MalfunctionMay 21, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  A TRILOGY EVO WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR PREVENTIVE MAINTENANCE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION A VENTILATOR INOPERATIVE ALARM INDICATING A MACHINE FLOW DRIFT WAS OBSERVED IN THE DOWNLOADED EVENT LOG. THE DEVICE'S MACHINE FLOW SENSOR WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, NOT RELATED TO THE REPORTABLE ISSUE, A MOTOR CONTROLLER SHUTDOWN ALARM AND A SYSTEM BOARD DRIFT ALARM WAS OBSERVED. THE DEVICE'S BLOWER ASSEMBLY AND SYSTEM BOARD WERE REPLACED TO ADDRESS THE ISSUES. THESE ISSUES WOULD NOT AFFECT THE DEVICE'S ABILITY TO DELIVER THERAPY AS DESIGNED. THE DEVICE WAS TESTED AND PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25244290 ↗
• MalfunctionMay 20, 2026Electrical /Electronic Property Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY EVO VENTILATOR HAD A VENTILATOR INOPERABLE CONDITION NOT OTHERWISE DEFINED WHICH IS A DEVICE PERFORMANCE AND SAFETY DEFICIENCY. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, THE MANUFACTURER IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25230246 ↗
• MalfunctionMay 8, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED ERROR CODE WAS FOUND ON A GARBIN EVO. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE, INTERNAL BATTERY NOT DETECTED AND SOFT POWER FAIL, WERE OBSERVED ON THE DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE TECHNICIAN FURTHER EVALUATED AND DETERMINED THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) HAD CAUSED THESE TWO ERROR CODES TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S SYSTEM PCA WAS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE AIR INLET FOAM FILTER AND PARTICULATE FILTER WERE REPLACED FOR PREVENTATIVE MAINTENANCE UNRELATED TO THE REPORTABLE ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125725 ↗
• MalfunctionApr 14, 2026Electrical /Electronic Property Problem; Battery Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A MAINTENANCE REQUIRED ALARM OCCURRED ON A GARBIN EVO / TRILOGY EVO VENTILATOR. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING THE EVALUATION AT THE THIRD-PARTY SERVICE CENTER, TWO VENTILATOR SERVICE REQUIRED ERROR CODES WERE FOUND IN THE DEVICE'S ERROR LOG RELATING TO 'INTERNAL BATTERY NOT DETECTED' AND 'PRESSURE SENSOR MISMATCH.' THE SERVICE TECHNICIAN STATES THAT THE PRESSURE SENSOR MISMATCH ERROR WAS CAUSED BY CONTAMINATION. THE MACHINE FLOW SENSOR, BLOWER CHASS TUBING, FIO2 TUBING, LOW FLOW O2 TUBING, AND SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) BOARD TUBING WERE CONTAMINATED WITH DUST AND WERE REPLACED TO RESOLVE THE ERROR. THERE IS NO DOCUMENTATION STATED ON A ROOT CAUSE AND/OR ANY COMPONENT REPLACEMENT TO RESOLVE THE INTERNAL BATTERY NOT DETECTED ERROR. ADDITIONALLY, THE DC HARNESS ASSEMBLY AND WARNING LABEL WERE DAMAGED. THE CONNECTOR COVER WAS MISSING. THE AIR INLET FOAM FILTER AND PARTICULATE FILTER WERE REPLACED FOR MAINTENANCE. AND A PM LABEL WAS ADDED TO THE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24880111 ↗
• MalfunctionApr 14, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED A REPORT THAT A GARBIN EVO VENTILATOR WAS RETURNED FOR MAINTENANCE SERVICE. THERE WERE NO REPORTS OR ALLEGATIONS OF PATIENT HARM OR INJURY. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING EVALUATION OF THE DEVICE AT A THIRD-PARTY SERVICE CENTER, THE DEVICE LOG FILES WERE SUCCESSFULLY DOWNLOADED AND FULLY REVIEWED. ANALYSIS IDENTIFIED MULTIPLE ¿VENT INOP¿ ALARMS. THESE ALARMS WERE ASSOCIATED WITH THE THERAPY CPU REMAINING IN BOOT MONITOR MODE AND MACHINE FLOW SENSOR DRIFT EXCEEDING SPECIFICATION LIMITS (>0.2 L/MIN). NO SPECIFIC COMPONENT FAILURE WAS IDENTIFIED TO DIRECTLY ADDRESS THE FLOW SENSOR DRIFT. TO ADDRESS THE CONDITION OF THE THERAPY CPU REMAINING IN BOOT MONITOR MODE, THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) WAS REPLACED. FURTHER LOG REVIEW IDENTIFIED ADDITIONAL ERROR CODES NOT DIRECTLY ASSOCIATED WITH THE REPORTED ISSUE, INCLUDING AN ERROR RELATED TO FAILURE DURING ERASE/WRITE OPERATIONS OF THE CALIBRATION DATA TABLE AND AN ERROR INDICATING EXCESSIVE SENSOR OFFSET DURING DRIFT CALCULATION. CORRECTION OF THESE CONDITIONS ALSO REQUIRED REPLACEMENT OF THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA). AN ADDITIONAL ERROR INDICATED THAT THE MOTOR CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24871983 ↗
• MalfunctionApr 1, 2026Battery Problem

  THE GARBIN EVO LINDE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR PREVENTATIVE MAINTENANCE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION AN ERROR CODE IN RELATION TO (INTERNAL BATTERY CANNOT BE DETECTED) WAS RECORDED IN THE DEVICE EVENT LOG. THE EVALUATION IS CURRENTLY IN PROCESS. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757096 ↗
• MalfunctionApr 1, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED A REPORT THAT A GARBIN EVO VENTILATOR WAS RETURNED FOR MAINTENANCE SERVICE. THERE WERE NO REPORTS OR ALLEGATIONS OF PATIENT HARM OR INJURY. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT A THIRD-PARTY SERVICE CENTER, THE DEVICE LOG FILES WERE SUCCESSFULLY DOWNLOADED AND REVIEWED IN FULL. A ¿VENT INOP¿ ALARM WAS IDENTIFIED, INDICATING THAT THE THERAPY CPU REMAINED IN BOOT MONITOR SOFTWARE. THE AVAILABLE SERVICE DOCUMENTATION DID NOT SPECIFY THAT ANY COMPONENTS REQUIRED REPLACEMENT TO RESOLVE THE ISSUE. NO ADDITIONAL ACTIONABLE ERROR CODES WERE IDENTIFIED. DUE TO THE 4-YEAR PREVENTIVE MAINTENANCE, THE AIR INLET FOAM FILTER, PARTICULATE FILTER AND MUFFLER WERE REPLACED. THE CUSTOMER COMPLAINT WAS CONFIRMED. THE DEVICE HAS BEEN SERVICED, INSPECTED, TESTED, AND MET ACCEPTANCE CRITERIA IN ACCORDANCE WITH ALL OF THE APPLICABLE CUSTOMER REQUIREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24752671 ↗
• MalfunctionMar 25, 2026Contamination; Pressure Problem

  A GARBIN EVO WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE, WITH AN ALLEGATION OF MAINTENANCE REQUIRED. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING EVALUATION OF THE TRILOGY EVO BY THE THIRD-PARTY SERVICE CENTER, AN ERROR CODE RELATED TO PRESSURE WAS FOUND IN THE ERROR LOG. EVT_PRESS_SENSOR_MISMATCH MEANS THE DEVICE SOFTWARE HAS DETECTED A LARGE PRESSURE DROP BETWEEN THE MONITOR AND OUTLET PRESSURE SENSORS (I.E. ACROSS THE MACHINE FLOW SENSOR). THE DEVICE'S MACHINE FLOW SENSOR WAS REPLACED DUE TO DUST CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688455 ↗
• MalfunctionMar 24, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A GARBIN EVO VENTILATOR REQUIRED MAINTENANCE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THE DEVICE LOG FILES WERE SUCCESSFULLY DOWNLOADED AND REVIEWED IN FULL. LOG REVIEW CONFIRMED THE OCCURRENCE OF A ¿VENTILATOR INOPERATIVE¿ ALARM RELATED TO THE MACHINE FLOW SENSOR. THIS ERROR INDICATES THAT THE MACHINE FLOW SENSOR DRIFTED ABOVE SPECIFICATION (>0.2 LPM). THE MACHINE FLOW SENSOR NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, FINDINGS UNRELATED TO THE REPORTED MALFUNCTION WERE IDENTIFIED. THE BLOWER REQUIRES REPLACEMENT DUE TO AN ALARM INDICATING THE MOTOR CONTROLLER HAS PROCEEDED TO THE SHUTDOWN STATE DUE TO AN ERROR WITH THE MOTOR. THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) NEEDS TO BE REPLACED DUE TO AN ERROR INDICATING THAT THE SENSOR OFFSET DURING DRIFT CALCULATION WAS TOO HIGH. AS PART OF ROUTINE PREVENTIVE MAINTENANCE, THE AIR INLET FOAM FILTER, MUFFLER ASSEMBLY, AND PARTICULATE FILTER NEED TO BE REPLACED. ADDITIONALLY, THE IN-LINE FILTER AND PROXIMAL FILTER WERE CONTAMINATED WITH DUST. A FINAL REPORT IS BEING SUBMITT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674030 ↗
• MalfunctionMar 19, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A GARBIN EVO VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER DUE TO MAINTENANCE REQUIRED. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. ON DEVICE EVALUATION, A VENTILATOR INOPERATIVE CODE E-155 HAD OCCURRED INDICATING THE MACHINE FLOW SENSOR DRIFT ABOVE THE SPECIFICATION AND REQUIRING REPLACEMENT OF THE MACHINE FLOW SENSOR TO ADDRESS THE ISSUE. FOUR-YEAR PREVENTATIVE MAINTENANCE WAS COMPLETED. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: A NON-CRITICAL DEVICE EVENT CODE E-144 WAS NOTED IN THE DEVICE ERROR LOG INDICATING THE MOTOR CONTROLLER HAS PROCEEDED TO THE SHUTDOWN STATE DUE TO AN ERROR WITH THE MOTOR AND REQUIRING REPLACEMENT OF THE BLOWER. A NON-CRITICAL EVENT CODE E-300 WAS NOTED IN THE DEVICE ERROR LOG INDICATING THE SENSOR OFFSET DURING DRIFT CALCULATION IS TOO HIGH AND REQUIRING REPLACEMENT OF THE SYSTEM PRINTED CIRCUIT BOARD ASSEMBLY TO RESOLVE. THE BLOWER BELLOWS, TUBING FIO2 AND TUBING LOW FLOW O2 WERE CONTAMINATED WITH DIRT. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE FOLLOWING THE COMPLETION OF THE DEVICE REPAIR THAT CHANGES THE OUTCOME OF THE INVESTIGATIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639844 ↗
• MalfunctionMar 19, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  A GARBIN EVO WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE GARBIN EVO WAS RETURNED AND EVALUATED BY THE THIRD-PARTY SERVICE CENTER. THE IN-PROCESS DEVICE EVALUATION FOUND A VENTILATOR INOPERATIVE ERROR CODE RELATED TO THE MACHINE FLOW SENSOR IN THE ERROR LOG. EVT_MACH_FLOW_DRIFT_HIGH MEANS THE MACHINE FLOW SENSOR DRIFT ABOVE THE SPECIFICATION (GREATER THAN 0.2LPM). THE MACHINE FLOW SENSOR NEEDS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, A NON-REPORTABLE ERROR CODE RELATED TO THE MOTOR CONTROLLER WAS FOUND IN THE ERROR LOG. EVT_MCL_FOC_SHUTDOWN MEANS THE MOTOR CONTROLLER HAS PROCEEDED TO THE SHUTDOWN STATE DUE TO AN ERROR WITH THE MOTOR. THE BLOWER NEEDS REPLACED TO ADDRESS THE ISSUE. ALSO, A NON-REPORTABLE ERROR CODE RELATED TO SENSOR OFFSET WAS FOUND IN THE ERROR LOG. EVT_DRIFT_DEBUG MEANS SENSOR OFFSET DURING DRIFT CALCULATION IS TOO HIGH. THE SYSTEM BOARD NEEDS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639502 ↗
• MalfunctionMar 19, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  A GARBIN EVO WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE GARBIN EVO WAS RETURNED AND EVALUATED BY THE THIRD-PARTY SERVICE CENTER. THE IN-PROCESS DEVICE EVALUATION FOUND A VENTILATOR INOPERATIVE ERROR CODE RELATED TO THE MACHINE FLOW SENSOR IN THE ERROR LOG. EVT_MACH_FLOW_DRIFT_HIGH MEANS THE MACHINE FLOW SENSOR DRIFT ABOVE THE SPECIFICATION (GREATER THAN 0.2LPM). THE MACHINE FLOW SENSOR NEEDS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, A NON-REPORTABLE ERROR CODE RELATED TO THE MOTOR CONTROLLER WAS FOUND IN THE ERROR LOG. EVT_MCL_FOC_SHUTDOWN MEANS THE MOTOR CONTROLLER HAS PROCEEDED TO THE SHUTDOWN STATE DUE TO AN ERROR WITH THE MOTOR. THE BLOWER NEEDS REPLACED TO ADDRESS THE ISSUE. ALSO, A NON-REPORTABLE ERROR CODE RELATED TO SENSOR OFFSET WAS FOUND IN THE ERROR LOG. EVT_DRIFT_DEBUG MEANS SENSOR OFFSET DURING DRIFT CALCULATION IS TOO HIGH. THE SYSTEM BOARD NEEDS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639197 ↗
• MalfunctionMar 19, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A GARBIN EVO VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER DUE TO MAINTENANCE REQUIRED. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. ON DEVICE EVALUATION, VENTILATOR INOPERATIVE DEVICE ERROR CODE E-155 WAS NOTED IN THE DEVICE ERROR LOG INDICATING THE MACHINE FLOW SENSOR DRIFT WAS ABOVE THE SPECIFICATION. REPLACEMENT OF THE MACHINE FLOW SENSOR IS REQUIRED TO RESOLVE THE ISSUE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: THE MACHINE FLOW SENSOR, BLOWER AND PROXIMAL FILTERS WERE CONTAMINATED WITH DUST AND REQUIRE REPLACEMENT. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE FOLLOWING THE COMPLETION OF THE DEVICE REPAIR THAT CHANGES THE OUTCOME OF THE INVESTIGATION AND ASSOCIATED MEDICAL DEVICE REPORTING A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639193 ↗
• MalfunctionMar 18, 2026Circuit Failure; Electrical /Electronic Property Problem; Device Sensing Problem

  A GARBIN EVO WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE GARBIN EVO WAS RETURNED AND EVALUATED BY THE THIRD-PARTY SERVICE CENTER. THE IN-PROCESS DEVICE EVALUATION FOUND A VENTILATOR INOPERATIVE ERROR CODE RELATED TO THE MACHINE FLOW SENSOR AND A VENTILATOR INOPERATIVE ERROR CODE RELATED TO THE THERAPY CPU IN THE ERROR LOG. EVT_MACH_FLOW_DRIFT_HIGH MEANS THE MACHINE FLOW SENSOR DRIFT ABOVE THE SPECIFICATION (GREATER THAN 0.2LPM). THE MACHINE FLOW SENSOR NEEDS REPLACED TO ADDRESS THE ISSUE. EVT_TPY_HELD_IN_BM MEANS THE THERAPY CPU IS STILL RUNNING IN BOOT MONITOR SOFTWARE. THE SYSTEM BOARD NEEDS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, A NON-REPORTABLE ERROR CODE RELATED TO THE MOTOR CONTROLLER WAS FOUND IN THE ERROR LOG. EVT_MCL_FOC_SHUTDOWN MEANS THE MOTOR CONTROLLER HAS PROCEEDED TO THE SHUTDOWN STATE DUE TO AN ERROR WITH THE MOTOR. THE BLOWER NEEDS REPLACED TO ADDRESS THE ISSUE. ALSO, A NON-REPORTABLE ERROR CODE RELATED TO SENSOR OFFSET WAS FOUND IN THE ERROR LOG. EVT_DRIFT_DEBUG MEANS SENSOR OFFSET DURING DRIFT CALCULATION IS TOO HIGH. THE SYSTEM BO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24630181 ↗
• MalfunctionMar 18, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  A GARBIN EVO WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE GARBIN EVO WAS RETURNED AND EVALUATED BY THE THIRD-PARTY SERVICE CENTER. THE IN-PROCESS DEVICE EVALUATION FOUND A VENTILATOR INOPERATIVE ERROR CODE RELATED TO THE MACHINE FLOW SENSOR IN THE ERROR LOG. EVT_MACH_FLOW_DRIFT_HIGH MEANS THE MACHINE FLOW SENSOR DRIFT ABOVE THE SPECIFICATION (GREATER THAN 0.2LPM). THE MACHINE FLOW SENSOR NEEDS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, A NON-REPORTABLE ERROR CODE RELATED TO THE MOTOR CONTROLLER WAS FOUND IN THE ERROR LOG. EVT_MCL_FOC_SHUTDOWN MEANS THE MOTOR CONTROLLER HAS PROCEEDED TO THE SHUTDOWN STATE DUE TO AN ERROR WITH THE MOTOR. THE BLOWER NEEDS REPLACED TO ADDRESS THE ISSUE. ALSO, THE PROXIMAL FILTERS NEEDS REPLACED DUE TO DUST/DIRT CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24627423 ↗
• MalfunctionMar 6, 2026Contamination; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING MAINTENANCE WAS REQUIRED ON A GARBIN EVO VENTILATOR. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THERE WAS NO REPORT OF HARM OR INJURY. THE GARBIN EVO VENTILATOR WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE IN RELATION TO (THE DEVICE SOFTWARE HAS DETECTED A LARGE PRESSURE DROP BETWEEN THE MONITOR AND OUTLET PRESSURE SENSORS) WAS RECORDED IN THE DEVICE EVENT LOG. THE TECHNICIAN CONFIRMED THE EVENT WAS CAUSED BY CONTAMINATION IN THE MACHINE FLOW SENSOR. IN CONCLUSION THE MACHINE FLOW SENSOR, BLOWER, BELLOW AND PROXIMAL IN-LINE FILTERS WERE REPLACED TO ADDRESS THE ISSUE. THE DEVICE PASSED ALL TESTING. ADDITIONALLY, DURING THE EVALUATION AND ERROR CODE IN RELATION TO (SOFT POWER FAIL) WAS RECORDED IN THE DEVICE EVENT LOG UNRELATED TO THE REPORTABLE MALFUNCTION. PREVENTIVE MAINTENANCE WAS PERFORMED THEREFORE THE FOLLOWING PARTS WERE REPLACED: MUFFLER ASSEMBLY, PARTICULATE FILTER, AIR INLET FOAM FILTER. THIS DEVICE HAS BEEN SERVICED, INSPECTED, TESTED, MET ACCEPTANCE CRITERIA IN ACCORDANCE WITH ALL OF THE APPLICABLE CUSTOMER REQUIREMENTS AS DEFINED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24536308 ↗