Trilogy 00 (REF CA1032800)Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00606959022782), received between Sep 29, 2015 and Jun 18, 2026 — classified as 63 malfunctions.

The most frequently reported specific device problem is “Failure to Calibrate” (20 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2026Circuit Failure; Failure to Calibrate

  A TRILOGY 200 WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED A TEST STEP RELATED TO THE NURSE CALL FUNCTION DURING TESTING. THE DEVICE'S INTERFACE BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25545908 ↗
• MalfunctionJun 12, 2026Circuit Failure; Failure to Calibrate

  A TRILOGY 200 WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED A TEST STEP RELATED TO THE NURSE CALL FUNCTION DURING TESTING. THE DEVICE'S INTERFACE BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25486793 ↗
• MalfunctionJun 4, 2026Failure to Calibrate; Device Sensing Problem

  A TRILOGY 200 WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED A CHECK LEAK TEST STEP DURING TESTING. THE DEVICE'S SYSTEM BOARD TO SENSOR BOARD CABLE WAS REPLACED AND A KINKED HOSE WAS ADJUSTED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25393331 ↗
• MalfunctionJun 3, 2026Circuit Failure; Mechanical Problem; Failure to Calibrate

  A TRILOGY 200 WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION THE DEVICE FAILED THE ACTIVE EXHALATION PROPORTIONAL VALVE OPEN AND A CHECK LEAK SENSOR TUBING TEST STEPS DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE, SYSTEM BOARD AND O2 TUBING WERE REPLACED TO ADDRESS THE ISSUES. ADDITIONALLY, NOT RELATED TO THE REPORTABLE ISSUES, SEVERAL COMPONENTS WERE REPLACED DUE TO MISSING/PHYSICAL DAMAGE. THE DEVICE WAS RE-TESTED AFTER REPAIR AND PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25372441 ↗
• MalfunctionJun 2, 2026Battery Problem

  A TRILOGY 200 WAS RETURNED TO THE MANUFACTURER FOR PREVENTIVE MAINTENANCE. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO EVIDENCE THE DEVICE WAS IN PATIENT USE. DURING THE EVALUATION A SERVICE REQUIRED ALARM CONDITION INDICATING AN INTERNAL BATTERY WAS OBSERVED IN THE DEVICE'S DOWNLOADED EVENT LOG. THE INTERNAL BATTERY NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, NOT RELATED TO THE REPORTABLE EVENT, AN ALARM CONDITION INDICATING A DETACHABLE BATTERY ISSUE WAS OBSERVED. THE DETACHABLE BATTERY NEEDS TO BE REPLACED. THE DEVICE'S RUBBER FEET, HANDLE, BASE ENCLOSURE, HUMIDIFIER PLUG, BUTTON AND KEYPAD NEED REPLACED DUE TO MISSING/PHYSICAL DAMAGE. NO COMPONENTS HAVE BEEN REPLACED DUE TO AWAITING PARTS RECEIPT. 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 25361104 ↗
• MalfunctionJun 2, 2026Thermal Decomposition of Device; Circuit Failure; Failure to Calibrate; Calibration Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY 200 VENTILATOR DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. DURING THE EVALUATION, THE SERVICE TECHNICIAN OBSERVED FAILURES OF TEST DP NULL VALVE, TEST DP PURGE VALVES, AND TEST PRESSURE AUTO-NULL VALVE. THE PRINTED CIRCUIT ASSEMBLY (PCA) WAS FOUND TO BE BURNED AND REQUIRED A REPLACEMENT FOR THE O2 SENSOR. ADDITIONALLY, THE POWER CORD CLAMP WAS MISSING, THE REAR ENCLOSURE ASSEMBLY WAS CRACKED, THE ENCLOSURE SEAL KIT NEEDED REAR CHANGED, THE BASE ENCLOSURE WAS CRACKED, THE EXHALATION PORT BLOCK WAS CRACKED, AND THE LABELS WERE UNACCEPTABLE. A REQUEST WAS PUT IN TO HAVE THE DEVICE SCRAPPED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25361084 ↗
• MalfunctionMay 22, 2026Electrical /Electronic Property Problem; Mechanical Problem; Battery Problem

  THE TRILOGY 200 VENTILATOR WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR REMEDIATION. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION THE DEVICE THE TECHNICIAN CONFIRMED A VENTILATOR INOPERATIVE CONDITION OCCURRED. IN CONCLUSION THE INTERNAL BATTERY AND BLOWER ASSEMBLY WERE REPLACED TO RESOLVE THE ISSUE. THE DEVICE WAS RETESTED AND PAST. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, COMPONENTS WERE REPLACED DUE TO COSMETIC/PHYSICAL DAMAGE OR AS PART OF MAINTENANCE OF THE DEVICE. THE SOFTWARE WAS UPGRADED UNRELATED TO THE REPORTABLE MALFUNCTION/ISSUE. THIS DEVICE BEEN SERVICED, INSPECTED, TESTED, MET ACCEPTANCE CRITERIA IN ACCORDANCE WITH ALL THE APPLICABLE CUSTOMER REQUIREMENTS AS DEFINED IN THE CONTRACTUAL AGREEMENT WITH PLEXUS. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND APPROVED BY PLEXUS QUALITY ASSURANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25254170 ↗
• MalfunctionMay 20, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE TRILOGY 200 VENTILATOR WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR REMEDIATION. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION IT WAS NOTED THE DEVICE FAILED A 120 VAC POWER SOURCE PEAK POWER (1 *) [19M 11S TEST STEP DURING TESTING. INCONCLUSION THE ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS RETESTED AND PASSED ALL TEST. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, COMPONENTS WERE REPLACED AS PART OF MAINTENANCE OF THE DEVICE OR DUE TO COSMETIC OR PHYSICAL DAMAGE. THE SOFTWARE WAS UPGRADED. THIS DEVICE BEEN SERVICED, INSPECTED, TESTED, MET ACCEPTANCE CRITERIA IN ACCORDANCE WITH ALL THE APPLICABLE CUSTOMER REQUIREMENTS AS DEFINED IN THE CONTRACTUAL AGREEMENT WITH PLEXUS. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND APPROVED BY PLEXUS QUALITY ASSURANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25228053 ↗
• MalfunctionMay 11, 2026Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR STOPPED PROVIDING VENTILATION WITH AUDIBLE ALARM. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION AND THE CUSTOMER¿S COMPLAINT WAS NOT CONFIRMED. 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 25144633 ↗
• MalfunctionMay 6, 2026Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT THE ACTIVE EXHALATION PURGE, ACTIVE PROPORT VALVE, AND CHECK LEAK TEST STEPS HAD FAILED ON A TRILOGY 200 DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY 200 DEVICE WAS BEING EVALUATED AT THE THIRD-PARTY SERVICE CENTER WHEN THESE TEST STEPS HAD FAILED ON THE DEVICE. DURING THE EVALUATION IT WAS NOTED THAT A MISASSEMBLE IN THE TRANSITION TUBE OF THE BLOWER ASSEMBLY HAD CAUSE THE ACTIVE EXHALATION PURGE, ACTIVE PROPORT VALVE, AND CHECK LEAK TEST STEPS TO FAIL ON THE DEVICE. IN CONCLUSION, THE DEVICE'S TRANSITION TUBE WAS PROPERLY REASSEMBLED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE FRONT ENCLOSURE AND HANDLE ASSEMBLY WERE REPLACED FOR PHYSICAL DAMAGE UNRELATED TO THE REPORTABLE ISSUE. THE HUMIDIFIER FEET AND POWER CORD CLAMP WERE REPLACED SINCE THESE PARTS WERE MISSING ON THE DEVICE. THIS WAS UNRELATED TO THE REPORTABLE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25104659 ↗
• MalfunctionApr 7, 2026Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE 120 VAC POWER SOURCE PEAK POWER TEST STEP HAD FAILED ON A TRILOGY 200 DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY 200 DEVICE WAS BEING EVALUATED BY A THIRD-PARTY SERVICE CENTER WHEN THE ISSUE OCCURRED ON THE DEVICE. DURING THE EVALUATION, THERE IS NO DOCUMENTATION STATED ON A ROOT CAUSE AND/OR ANY COMPONENT REPLACEMENT TO RESOLVE THE 120 VAC POWER SOURCE PEAK POWER TEST STEP FAILING ON THE TRILOGY 200 DEVICE. IN CONCLUSION, THE THIRD-PARTY SERVICE TECHNICIAN RESET THE DEVICE TO ADDRESS THE ISSUE. THE ROOT CAUSE ISN'T CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE HANDLE O-RING, RUBBER FEET, AND POWER CORD CLAMP WERE REPLACED DUE TO MISSING ON THE DEVICE. THESE WERE UNRELATED TO THE REPORTED ISSUE. THE HANDLE ASSEMBLY AND UNIVERSAL PORTING BLOCK WERE REPLACED FOR PHYSICAL DAMAGE UNRELATED TO THE REPORTABLE ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24809691 ↗
• MalfunctionApr 7, 2026Calibration Problem

  A TRILOGY 200 VENTILATOR WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING THE EVALUATION AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED A TEST STEP RELATING TO 'DP PURGE VALVES OPENED.' THERE IS NO DOCUMENTATION STATED ON A ROOT CAUSE AND/OR ANY COMPONENT REPLACEMENT TO RESOLVE THE FAILED. IT IS NOTED THAT THE DEVICE WAS SENT BACK FOR RUN IN TESTING AND PASSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24803330 ↗
• MalfunctionApr 7, 2026Failure to Calibrate

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY 200 VENTILATOR WAS RETURNED FOR SERVICE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY ASSOCIATED WITH THIS EVENT. THE DEVICE WAS EVALUATED AT A THIRD-PARTY SERVICE CENTER. VISUAL INSPECTION IDENTIFIED THAT THE POWER CORD CLAMP AND RUBBER FEET WERE MISSING, AND THAT THE UNIVERSAL PORTING BLOCK AND WARNING LABEL WERE DAMAGED. FUNCTIONAL TESTING IDENTIFIED A FAILURE DURING THE HW POWER FAIL TEST. REVIEW OF AVAILABLE SERVICE DOCUMENTATION DID NOT INDICATE THAT REPLACEMENT OF ANY COMPONENTS WAS NECESSARY TO ADDRESS THIS CONDITION. THE DEVICE WAS RESET AND SUBSEQUENTLY RETESTED. FOLLOWING REPAIR, THE DEVICE SUCCESSFULLY PASSED ALL REQUIRED FUNCTIONAL AND PERFORMANCE TESTING. A FINAL REPORT IS BEING SUBMITTED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24798845 ↗
• MalfunctionApr 7, 2026Mechanical Problem; Failure to Calibrate

  THE TRILOGY 200 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR REMEDIATION. THE DEVICE WAS NOT IN USE BY A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE SERVICE OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED THE ACTIVE EXHALATION PURGE VALVE CLOSED AND ACTIVE EXHALATION PROPORTIONAL VALVE OPEN TEST STEP DURING TESTING. IN CONCLUSION, THE DEVICE'S TRILOGY ACTIVE EXHALATION CONTROL MODULE WAS REPLACED, AND TUBE REASSEMBLY WAS REQUIRED TO ADDRESS THE ISSUE. THE DEVICE PASSED ALL TESTING. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, MULTIPLE COMPONENTS WERE REPLACED DUE TO COSMETIC, PHYSICAL DAMAGE AND MISSING PARTS UNRELATED TO THE REPORTABLE MALFUNCTION/ISSUE. THIS DEVICE BEEN SERVICED, INSPECTED, TESTED, MET ACCEPTANCE CRITERIA IN ACCORDANCE WITH ALL THE APPLICABLE CUSTOMER REQUIREMENTS AS DEFINED IN THE CONTRACTUAL AGREEMENT WITH PLEXUS. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND APPROVED BY PLEXUS QUALITY ASSURANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24797832 ↗
• MalfunctionFeb 26, 2026Circuit Failure; Failure to Calibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED THE DP PURGE VALVES TEST STEP DURING TESTING. THE DEVICE'S SENSOR BOARD NEEDS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, UNRELATED TO THE TEST FAILURE, DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE WAS FOUND TO HAVE MISSING FEET, THE POWER CORD CLAMP WAS FOUND TO BE MISSING AND THE BASE ENCLOSURE WAS FOUND TO BE DAMAGED. FEET, POWER CORD CLAMP AND BASE ENCLOSURE NEEDS REPLACED TO ADDRESS THE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456314 ↗
• MalfunctionFeb 10, 2026Mechanical Problem; Failure to Calibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED THE O2 LOW FLOW TEST STEP DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROLLER NEEDS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, UNRELATED TO THE TEST FAILURE, DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE PORTING BLOCK PORT WAS FOUND TO BE CRACKED, THE CORD RETAINER WAS FOUND TO BE MISSING/BROKEN, THE REAR & BASE ENCLOSURES WERE FOUND TO BE DAMAGED, AND THE DEVICE WAS FOUND TO HAVE MISSING/DISPLACED RUBBER FEET. THE UNIVERSAL PORTING BLOCK, THE CABLE CLAMP, THE REAR CASE ENCLOSURE AND BASE ENCLOSURE ASSEMBLY NEED TO BE REPLACED TO ADDRESS THE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24306125 ↗
• MalfunctionFeb 10, 2026Circuit Failure; Mechanical Problem; Failure to Calibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED THE ACTIVE EXHALATION PROPORTIONAL VALVE TEST STEP DURING TESTING. THE DEVICE'S SYSTEM/CPU BOARD NEEDS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, UNRELATED TO THE TEST FAILURE, DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE WAS FOUND TO HAVE MISSING/DISPLACED RUBBER FEET, THE PORTING BLOCK PORT WAS FOUND TO BE PINCHED/DAMAGED, THE CORD RETAINER WAS FOUND TO BE MISSING/BROKEN AND THE HANDLE WAS FOUND TO BE CRACKED. ENCLOSURE FEET, THE UNIVERSAL PORTING BLOCK, THE CABLE CLAMP AND HANDLE NEED TO BE REPLACED TO ADDRESS THE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24305971 ↗
• MalfunctionFeb 9, 2026Failure to Calibrate; Improper Flow or Infusion

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED THE POSITIVE FLOW VERIFICATION TEST STEP DURING TESTING. THE DEVICE NEEDS TO BE RECALIBRATED TO ADDRESS THE ISSUE. ADDITIONALLY, UNRELATED TO THE TEST FAILURE, DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE WAS FOUND TO HAVE MISSING/DISPLACED RUBBER FEET, THE PORTING BLOCK PORT WAS FOUND TO BE PINCHED/DAMAGED, THE CORD RETAINER WAS FOUND TO BE MISSING/BROKEN, AND THERE WAS DAMAGE TO THE REAR ENCLOSURE. ENCLOSURE FEET, UNIVERSAL PORTING BLOCK, CABLE CLAMP AND REAR CASE ENCLOSURE NEED TO BE REPLACED TO ADDRESS THE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24294877 ↗
• MalfunctionFeb 6, 2026Failure to Calibrate; Battery Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED A TEST STEP DURING TESTING WHICH RESULTED IN AN ERROR CODE RELATED TO THE BATTERY. ERR_BATT_LOW_STATE_OF_HEALTH_INT_LI_ION MEANS THE INTERNAL LI-ION STATE OF HEALTH <= 50%. FULL CHARGE CAPACITY (FCC) IS LESS THAN 51% OF THE DESIGN CAPACITY. THE DEVICE'S INTERNAL BATTERY PACK WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, UNRELATED TO THE TEST FAILURE, DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE WAS FOUND TO HAVE MISSING/DISPLACED RUBBER FEET SO ENCLOSURE FEET WERE REPLACED. THE PORTING BLOCK PORT WAS FOUND TO BE PINCHED/DAMAGED SO THE UNIVERSAL PORTING BLOCK WAS REPLACED. THE CORD RETAINER WAS MISSING OR BROKEN SO THE CABLE CLAMP WAS REPLACED AND THE HANDLE WAS REPLACED DUE TO IT BEING CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24281034 ↗
• MalfunctionFeb 6, 2026Failure to Calibrate; Infusion or Flow Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED THE POSITIVE FLOW VERIFY TEST STEP DURING TESTING. THE DEVICE WAS RECALIBRATED TO ADDRESS THE ISSUE. ADDITIONALLY, UNRELATED TO THE TEST FAILURE, DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE WAS FOUND TO HAVE THE PORTING BLOCK PORT PINCHED/DAMAGED SO THE UNIVERSAL PORTING BLOCK WAS REPLACED. THE CORD RETAINER WAS FOUND TO BE MISSING/BROKEN SO THE CABLE CLAMP WAS REPLACED. THE STIRRING FAN, EXHAUST FAN, TUBING, FRONT CASE, REAR CASE, AND BASE ENCLOSURE ASSEMBLY REPLACED DUE TO TOBACCO CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280114 ↗
• MalfunctionJan 28, 2026Mechanical Problem; Failure to Calibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED THE ACTIVE EXHALATION PROPORTIONAL VALVE TEST STEP DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROLLER NEEDS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, UNRELATED TO THE TEST FAIL, THE DEVICE WAS FOUND TO BE MISSING FEET, THE POWER CORD CLAMP WAS FOUND TO BE MISSING AND THE PASSIVE PORTING BLOCK WAS FOUND TO BE DAMAGED. NECESSARY PARTS REPLACED TO ADDRESS THE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24201884 ↗
• MalfunctionJan 21, 2026Circuit Failure; Failure to Calibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED THE DP CALIBRATION TEST STEP DURING TESTING. THE DEVICE'S SENSOR BOARD AND INTERFACE BOARD NEEDS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, UNRELATED TO THE TEST FAILURE, THE DEVICE WAS FOUND TO HAVE FEET MISSING, THE POWER CORD CLAMP WAS MISSING, THE REAR CASE ENCLOSURE WAS DAMAGED AND THE PORTING BLOCK ADAPTER WAS DAMAGED. NECESSARY PARTS REPLACED TO ADDRESS ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24133714 ↗
• MalfunctionJan 16, 2026Display or Visual Feedback Problem; Failure to Calibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED THE LCD BACKLIGHT TEST STEP DURING TESTING. THE DEVICE'S FRONT PANEL BOARD WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, UNRELATED TO THE TEST FAILURE, THE DEVICE WAS FOUND TO HAVE MISSING/DISPLACED RUBBER FEET, THE PORTING BLOCK WAS FOUND TO BE PINCHED/DAMAGED AND THE CORD RETAINER WAS MISSING/BROKEN. NECESSARY PARTS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24097393 ↗
• MalfunctionJan 15, 2026Circuit Failure; Electrical /Electronic Property Problem; Mechanical Problem; Failure to Power Up

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY REPORTED. THE DEVICE WAS NOT REPORTED TO BE IN CLINICAL USE. DURING THE EVALUATION OF THE DEVICE AT A THIRD-PARTY SERVICE CENTER, A VENTILATOR INOPERATIVE ERROR WAS CONFIRMED IN THE EVENT LOG. THE DEVICE'S BLOWER NEEDS TO BE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24080827 ↗
• MalfunctionJan 8, 2026Circuit Failure; Failure to Calibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED THE O2 LOW FLOW TEST STEP DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE BOARD WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, UNRELATED TO THE TEST FAIL, THE DEVICE WAS FOUND TO HAVE MISSING/DISPLACED RUBBER FEET, SO THE ENCLOSURE FEET WERE REPLACED AND THE CORD RETAINER WAS FOUND TO BE MISSING/BROKEN, SO THE CABLE CLAMP WAS REPLACED. ALSO, THE THERMISTOR WAS FOUND TO NOT BE CONNECTED, SO IT WAS RE-CONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24005219 ↗