Trilogy Evo BL2110X15BRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00606959055520), received between Nov 8, 2022 and May 28, 2026 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (14 reports).

4 FDA recall records name this device's identifier, 4 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 16, 2026.

Recalls naming this device

1. Oct 7, 2024Open, 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-0291-2025 · Root cause: Device Design · Recall details · FDA record ↗

2. Jul 16, 2024Open, 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, 2024Open, Classified

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

   Z-1504-2024 · Root cause: Device Design · Recall details · FDA record ↗

4. Nov 27, 2023Open, Classified

   The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. The AVAPS feature is contraindicated for patients less than 10 kg. Potential harms if devices are used on contraindicated patients include barotrauma, hypoventilation/hypercapnia, and rebreathing of excessive CO2.

   Z-0638-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Circuit Failure; Electrical /Electronic Property Problem; Mechanical Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT A TRILOGY EVO BENELUX DEVICE FAILED A PERFORMANCE VERIFICATION (PV) TEST FOR INTERNAL LEAK. THERE WAS NO ALLEGATION OF PATIENT HARM, AND THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE AT THE TIME OF THE EVENT. THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25325757 ↗
• MalfunctionFeb 13, 2026Electrical /Electronic Property Problem; Battery Problem; Power Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY EVO VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. IT WAS REPORTED THE DEVICE EXPERIENCED ERROR CODES E-206, E-207, AND E-325. THESE ERROR CODES INDICATE BOTH SOFT POWER FAIL AND HARD POWER FAIL; THE DEVICE TURNS OFF AND ASSOCIATED AUDIO AND VISUAL ALARMS OCCURRED ASSOCIATED WITH BATTERY DEPLETION. ALTHOUGH THERE WAS NO PATIENT HARM OR INJURY, THIS EVENT IS REPORTABLE BECAUSE THE FAILURE COULD AFFECT THE ABILITY OF THE DEVICE TO PROVIDE THERAPY TO PUBLISHED SPECIFICATIONS. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE ALLEGED MALFUNCTION IS NOT ABLE TO BE CONFIRMED AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION HAS BEEN COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24335445 ↗
• MalfunctionJan 15, 2026Circuit Failure; Electrical /Electronic Property Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A POWER V_BUS DROPPED (E-0325) ERROR CODE HAD OCCURRED ON A TRILOGY EVO DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. PHILIPS IS CURRENTLY INVESTIGATING THIS COMPLAINT; HOWEVER, THE DEVICE EXAMINATION HAS NOT BEGUN BECAUSE THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. AS PART OF THE COMPLAINT HANDLING PROCESS, THE MANUFACTURER WILL ATTEMPT TO RETRIEVE THE DEVICE FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24080498 ↗
• MalfunctionJan 14, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATION INOPERATIVE ALARM HAD OCCURRED ON A TRILOGY EVO DEVICE. THE CUSTOMER STATED THAT ERROR CODE, MACHINE FLOW DRIFT HIGH (E-0155), WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. ADDITIONALLY, THE CUSTOMER MENTIONED THAT TWO ADDITIONAL NONREPORTABLE ERROR CODES, EVENT DRIFT DEBUG (E-0330) AND MOTOR CONTROLLER FORCE SHUTDOWN(E-0144), WERE OBSERVED ON THE DEVICE'S ERROR LOG FOR THIS DEVICE. PHILIPS IS CURRENTLY INVESTIGATING THIS COMPLAINT; HOWEVER, THE DEVICE EXAMINATION HAS NOT BEGUN BECAUSE THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. AS PART OF THE COMPLAINT HANDLING PROCESS, THE MANUFACTURER WILL ATTEMPT TO RETRIEVE THE DEVICE FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24075257 ↗
• MalfunctionJan 14, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A SOFT POWER FAIL ERROR CODE (E-206) HAD OCCURRED ON A TRILOGY EVO DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY EVO DEVICE WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION IT WAS NOTED THAT THE DEVICES SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) HAD CAUSED THE 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 BLOWER ASSEMBLY NEEDS REPLACED FOR A NON-REPORTABLE ERROR CODE, INLET FILTER BLOCK (E-082), THAT WAS FOUND ON THE DEVICE'S ERROR LOG AND IS UNRELATED TO THE REPORTABLE ISSUE. THE SYSTEM PCA NEEDS REPLACING FOR ANOTHER NON-REPORTABLE ERROR CODE, HARD POWER FAIL (E-0208), THAT WAS FOUND ON THE DEVICE'S ERROR LOG AND IS UNRELATED TO THE REPORTABLE ISSUE. THE MACHINE FLOW SENSOR AND FIO2 TUBING NEEDS REPLACED FOR CONTAMINATION UNRELATED TO THE REPORTABLE ISSUE. THE FILER COVER NEEDS REPLACED FOR PHYSICAL DAMAGE UNRELATED TO THE REPORTABLE ISSUE. THE AIR FOAM INLET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24069742 ↗
• MalfunctionDec 19, 2025Electrical /Electronic Property Problem; Device Sensing Problem; Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED ALARM OCCURRED WHILE THE TRILOGY EVO, BENELUX DEVICE WAS IN PATIENT USE. THERE WAS NO ALLEGATION OF HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, AN ERROR INDICATING THE DEVICE SOFTWARE DETECTED A LARGE PRESSURE DROP BETWEEN THE MONITOR AND OUTLET PRESSURE SENSORS DISCOVERED IN THE EVENT LOG. THE ROOT CAUSE OF THE ERRORS FOUND IN LOG ARE CAUSED BY CLOGGED FILTERS IN THE UNIT. THE TECHNICIAN REPLACED THE DEVICE'S FLOW SENSOR TO ADDRESS THE ISSUE. ADDITIONALLY, THE DEVICE'S BLOWER ASSEMBLY, ONE IN-LINE FILTER PROX ASSY AND IN- LINE FILTER ARE CONTAMINATED AND HAVE BEEN REPLACED. THE CONNECTION COVER IS MISSING. THE DEVICE'S AIR FOAM INLET FILTER, MUFFLER AND PARTICULATE FILTER WILL BE REPLACED DUE TO THE 4 YEAR PREVENTIVE MAINTENANCE PROCEDURE. THE DEVICE HAS BEEN SERVICED, INSPECTED, TESTED, MET ACCEPTANCE CRITERIA IN ACCORDANCE WITH ALL OF THE APPLICABLE CUSTOMER REQUIREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851725 ↗
• MalfunctionDec 18, 2025Failure to Calibrate; Device Sensing Problem; Failure to Calibrate; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO BENELUX DEVICE FAILED THE "PNEUMATIC TEST" DURING ROUTINE PREVENTATIVE MAINTENANCE AT A THIRD-PARTY SERVICE CENTER. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE TRILOGY EVO BENELUX DEVICE AT THE THIRD-PARTY 'S SERVICE CENTER THE ROOT CAUSE OF THE MALFUNCTION WAS DETERMINED TO BE A DEFECTIVE MACHINE FLOW SENSOR. THE DEVICE'S MACHINE FLOW SENSOR WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, A FAILURE WAS DETECTED DURING A PRE-TEST WHERE IT FAILED ON THE "SENSOR DRIFT VERIFICATION" STEP DUE TO THE SYSTEM BOARD IS DEFECTIVE. THE SYSTEM BOARD WAS REPLACED TO ADDRESS THIS ISSUE. THE AIR FOAM INLET FILTER WAS REPLACED DUE TO PREVENTIVE MAINTENANCE REQUIREMENTS. THE DEVICE HAS BEEN SERVICED, INSPECTED, TESTED, MET ACCEPTANCE CRITERIA IN ACCORDANCE WITH ALL OF THE APPLICABLE CUSTOMER REQUIREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23843801 ↗
• MalfunctionNov 17, 2025Electrical /Electronic Property Problem; Mechanical Problem; Device Sensing Problem; Electrical /Electronic Property Problem; Mechanical Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION A TRILOGY EVO VENTILATOR WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR THE REPORT OF A VENTILATOR SERVICE REQUIRED ERROR CODE E-384, WHICH INDICATES THE DEVICE SOFTWARE HAS DETECTED 320788247. THERE 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 23569722 ↗
• MalfunctionOct 15, 2025Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING VENTILATOR INOPERATIVE ERROR CODES OCCURRED. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. EVT_TPY_HELD_IN_BM MEANS THERAPY CPU IS STILL RUNNING IN BOOT MONITOR SOFTWARE. EVT_POWER_VBUS_DROPPED MEANS V_BUS DROPPED BELOW 8.000V. ADDITIONALLY, NOT RELATED TO THE REPORTABLE VENTILATOR INOPERATIVE ERROR CODES, AN ERROR CODE RELATED TO THE AIR FILTER AND AN ERROR CODE RELATED TO THE CALIBRATION DATA TABLE OCCURRED. EVT_INLET_FILTER_BLK MEANS THE AIR FILTER ON THE BLOWER INTAKE IS CLOGGED. EVT_CAL_DATA MEANS ERASE OR WRITE A CALIBRATION DATA TABLE. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23300843 ↗
• MalfunctionSep 11, 2025Contamination; Electrical /Electronic Property Problem; Contamination; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION FROM A THIRD-PARTY SERVICE PROVIDER THAT A VENTILATOR INOPERATIVE ERROR HAD OCCURRED ON TRILOGY EVO DEVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THE DEVICE INVESTIGATION HAS YET NOT BEGUN. A FINAL REPORT WILL BE FILED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23031146 ↗
• MalfunctionSep 8, 2025Mechanical Problem; Failure to Calibrate; Mechanical Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO ACTIVE EXHALATION VALVE FAILURE SERVICE REQUIRED ALARM OCCURRED. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22991737 ↗
• MalfunctionSep 5, 2025Contamination; Electrical /Electronic Property Problem; Contamination; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED ALARM OCCURRED WHILE THE TRILOGY EVO (BENELUX) DEVICE WAS IN PATIENT USE. THERE WAS NO ALLEGATION OF HARM OR INJURY REPORTED. THE TRILOGY EVO (BENELUX) DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22979718 ↗
• MalfunctionJul 31, 2025Circuit Failure; Failure to Calibrate; Circuit Failure; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO DEVICE FAILED THE PV TEST FAIL P. PROX TEST. THERE WAS NO ALLEGATION OF PATIENT HARM. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE SERVICE CENTER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22676769 ↗
• MalfunctionJul 11, 2025Electrical /Electronic Property Problem; Failure to Power Up; Calibration Problem; Electrical /Electronic Property Problem; Failure to Power Up; Calibration Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING MULTIPLE VENTILATOR SERVICE REQUIRED CONDITIONS OCCURRED ON A TRILOGY EVO DEVICE. THE REPORTABLE ERROR CODES FOUND IN THE DEVICE'S ERROR LOG RELATE TO A SOFT POWER FAIL, A HARD POWER FAIL, AND A POWER VBUS DROPPED. A LOW PRIORITY ERROR CODE WAS ALSO NOTED RELATING TO A SOFTWARE UPGRADE FAILURE. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTIONS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22480993 ↗
• MalfunctionFeb 21, 2025Computer Software Problem; Electrical /Electronic Property Problem; Unexpected Shutdown; Computer Software Problem; Electrical /Electronic Property Problem; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21434063 ↗
• MalfunctionFeb 20, 2025Battery Problem; Battery Problem

  A VENTILATOR WAS RETURNED TO THE PRODUCT INVESTIGATION LABORATORY (PIL) FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S DETACHABLE BATTERY NEEDS TO BE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21422838 ↗
• MalfunctionFeb 20, 2025Battery Problem; Battery Problem

  A VENTILATOR WAS RETURNED TO THE PRODUCT INVESTIGATION LABORATORY (PIL) FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S DETACHABLE BATTERY NEEDS TO BE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21420529 ↗
• MalfunctionJul 16, 2024Failure to Calibrate; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE PRESSURE VERIFICATION PROXIMAL TEST FAILING ON THE DEVICE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19754518 ↗
• MalfunctionFeb 29, 2024Failure to Recalibrate; Failure to Recalibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED A TEST STEP. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18807429 ↗
• MalfunctionFeb 12, 2024Leak/Splash; Leak/Splash

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS ALARMING FOR LOW LEAKAGE. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE HAS BEEN RETURNED TO THE THIRD-PARTY SERVICE CENTER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE THIRD-PARTY SERVICE CENTER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18686996 ↗
• MalfunctionFeb 7, 2024Circuit Failure; Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18664264 ↗
• MalfunctionFeb 6, 2024Mechanical Problem; Failure to Recalibrate; Mechanical Problem; Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED A TEST STEP DURING TESTING. THE DEVICE'S MACHINE FLOW SENSOR NEEDS TO BE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18654066 ↗
• MalfunctionJan 11, 2024Electrical /Electronic Property Problem; Device Sensing Problem; Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18492166 ↗
• MalfunctionOct 27, 2023Circuit Failure; Circuit Failure

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE DUE TO A "FAN INOPERATIVE" ON THE DEVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A "PRESS SENSOR FAILURE" WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE PASSED ALL TESTING. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18022882 ↗
• MalfunctionJun 1, 2023Circuit Failure; Failure to Recalibrate; Circuit Failure; Failure to Recalibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED A TEST STEP. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037191 ↗