Trilogy 200 Trilogy 200 Bluetooth, U.S.A.Recalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 00606959026445), received between Sep 21, 2016 and Sep 25, 2026 — classified as 92 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (18 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 92 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902455 ↗
• MalfunctionSep 25, 2026Electrical /Electronic Property Problem

  The manufacturer received information alleging a cell undervoltage error code was observed on a Trilogy 100 device. 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, cell undervoltage, was observed on the device's error log. The service technician provided no documentation stated on a root cause and/or any component replacement to resolve the cell undervoltage error code. There was no repair information was provided, and no part(s) were replaced to address this issue. 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 supplemental report will be completed. The root cause isn't confirmed at this time. Additionally, during the service of the device, the rubber feet were replaced for missing on the device. This was unrelated to the reportable issue. The device passed all final testing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896040 ↗
• MalfunctionSep 2, 2026Circuit Failure; Failure to Calibrate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50565630 ↗
• MalfunctionJul 1, 2026Mechanical Problem; Failure to Calibrate

  THE TRILOGY 200 VENTILATOR WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR PREVENTATIVE MAINTENANCE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION IT WAS NOTED THE DEVICE RETURNED TO THE TECHNICIAN FOR ADDITIONAL EVALUATION DUE TO A FAILED ACTIVE EXHALATION PURGE VALVE CLOSED AND ACTIVE EXHALATION PROPORTIONAL VALVE OPEN TEST STEP DURING TESTING. THERE WERE NO SIGNIFICANT EVENT(S) IN THE ERROR LOG(S). ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE DEVICE FAILED TESTING FOR INTERNAL BATTERY CAPACITY THEREFORE THE INTERNAL BATTERY NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. ADDITIONAL COMPONENTS REQUIRED REPLACEMENT AS PART OF MAINTENANCE OF THE DEVICE OR DUE TO PHYSICAL/COSMETIC DAMAGE. THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25676612 ↗
• MalfunctionJun 10, 2026Circuit Failure; Electrical /Electronic Property Problem

  A TRILOGY 200 VENTILATOR DEVICE WAS RETURNED TO A SERVICE CENTER FOR RECERTIFICATION. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. DURING THE EVALUATION, THE SERVICE TECHNICIAN OBSERVED R VENT SERVICE REQUIRED ERROR CODES E201 (ERR_VSUPPLY_FAILURE) AND E202 (ERR_12V_FAILURE) IN THE ERROR LOG. THE SUPPLY VOLTAGE IS OUT OF RANGE FOR 10 SECONDS, DUE TO A POWER MANAGEMENT BOARD FAILURE. THE POWER MAY FAIL. THE SYSTEM AND POWER MANAGEMENT PRINTED CIRCUIT ASSEMBLY (PCA) WILL NEED TO BE REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, THE FEET WERE MISSING, THE CORD RETAINER WAS MISSING, THE WARNING LABEL WAS DAMAGED, THE HANDLE WAS CRACKED, THE PORTING BLOCK WAS CRACKED, THE OVERLAY DISPLAY WAS DAMAGED, AND THE MAC ADDRESS LABEL WAS ILLEGIBLE. THE DEVICE WAS DISQUALIFIED FROM RECERTIFICATION. DEVICE WILL BE SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25460380 ↗
• MalfunctionMay 29, 2026Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY 200 WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. ON DEVICE EVALUATION, THE DEVICE FAILED REPAIR TESTING DUE TO DIFFERENTIAL PRESSURE (DP) PURGE VALVES V3/V4 OPENED. THE DEVICE WAS RETURNED TO THE TECHNICIAN FOR ADDITIONAL EVALUATION WHERE THE TEST FAILURE WAS CONFIRMED. THE DEVICE PRINTED CIRCUIT BOARD ASSEMBLY REQUIRED REPLACEMENT TO ADDRESS THIS ISSUE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: PREVENTIVE MAINTENANCE WAS COMPLETED WITH REQUIRED COMPONENTS BEING REPLACED PER MAINTENANCE SCHEDULE. DEVICE ERROR CODE E-194 WAS NOTED INDICATING THE DETACHABLE BATTERY FAILED. THE DETACHABLE BATTERY IS AN OPTIONAL ACCESSORY, AND A FAILURE WOULD RESULT IN USE OF THE INTERNAL BATTERY. THE DETACHABLE BATTERY POWER IS USED FIRST, WITH THE INTERNAL BATTERY POWER AS A BACK-UP. THEREFORE, THIS SCENARIO WOULD NOT RESULT IN A LOSS OF THERAPY. MISSING AND/OR DAMAGED DEVICE COMPONENTS WERE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25331870 ↗
• MalfunctionMay 26, 2026Computer Software Problem; Failure to Calibrate

  A TRILOGY 200 WAS RETURNED TO THE MANUFACTURER FOR RECERTIFICATION. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO EVIDENCE THE DEVICE WAS IN PATIENT USE. DURING THE EVALUATION THERE WERE NO CRITICAL ERRORS OBSERVED IN THE DOWNLOADED EVENT LOG. SEVERAL COMPONENTS WERE REPLACED DUE TO MISSING/PHYSICAL DAMAGE. DURING FINAL TESTING THE DEVICE FAILED A PPROXIMAL PRESSURE VERIFICATION TEST STEP. THE DEVICE'S SENSOR TABLE WAS RECALIBRATED TO ADDRESS THE ISSUE. NO COMPONENTS WERE REPLACED FOR THIS ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25279199 ↗
• MalfunctionMay 21, 2026Circuit Failure; No Display/Image; Calibration Problem; Intermittent Communication Failure

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY 200 VENTILATOR DEVICE WAS RETURNED TO A SERVICE CENTER FOR SERVICE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. DURING THE EVALUATION, THE SERVICE TECHNICIAN OBSERVED THAT THE DEVICE FAILED TESTING FOR LCD SCREEN TEST. THE DEVICE WAS POWERED ON AND LEFT TO OPERATE. AFTER SEVERAL MINUTES, THE SCREEN WENT BLANK AND WAS ILLEGIBLE. IT WAS DETERMINED THAT THE TEST FAILURE WAS CAUSED BY A FAULTY SYSTEM BOARD PRINTED CIRCUIT ASSEMBLY (PCA). THE SYSTEM BOARD PCA WILL NEED TO BE REPLACED DUE TO THE TEST FAILURE. IN ADDITION, THE ENCLOSURE FEET WERE MISSING AND REPLACED, AND THE CAPACITOR AND FRONT CASE OVERLAY WERE REPLACED DUE TO PHYSICAL DAMAGE. THE INTERFACE PCA BOARD HAD A COMMUNICATION ISSUE AND WAS REPLACED, AND THE DETACHABLE BATTERY WILL NEED TO BE REPLACED DUE TO ERROR CODE E194 (ERR_PERM_FAIL_DET_LI_ION). THE DEVICE REPAIR HAD NOT BEEN COMPLETED THE SERVICE CENTER WAS STILL AWAITING PARTS. 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/SUPPLEME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25246754 ↗
• MalfunctionMay 20, 2026Electrical /Electronic Property Problem; Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY 100 VENTILATOR DEVICE WAS RETURNED TO A SERVICE CENTER FOR SERVICE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. DURING THE EVALUATION, THE SERVICE TECHNICIAN OBSERVED AN R VENTILATOR INOPERATIVE ERROR CODE E009 (ERR_DSP_MOTOR_FAILURE) IN THE ERROR LOG. THE BLOWER WILL BE REPLACED TO ADDRESS THE ERROR CODE. IN ADDITION, THE CORD RETAINER WAS MISSING AND REPLACED, THE KEYPAD, FRONT CASE, REAR CASE, BASE ENCLOSURE WITH LABELS AND FEET, HANDLE, AND ENCLOSURE TOP PLATE HAVE ALL BEEN REPLACED FOR PHYSICAL DAMAGE. THE PORTING BLOCK ADAPTER KIT HAD A BROKEN SCREW BOSS MOUNT AND WAS REPLACED, THE INTERFACE PCA WAS REPLACED DUE TO A COMMUNICATION FAILURE, AND THE EXHAUST FAN AND TUBING KIT WERE REPLACED DUE TO CONTAMINATION. THE DEVICE PASSED ALL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233006 ↗
• MalfunctionApr 8, 2026Circuit Failure; Electrical /Electronic Property Problem; Failure to Power Up

  THE MANUFACTURER RECEIVED A COMPLAINT REGARDING A TRILOGY 200 VENTILATOR THAT FAILED TO POWER ON AFTER BEING RETURNED FROM A PRIOR REPAIR. THE REPORTER INDICATED THAT THE DEVICE SCREEN DID NOT COME ON; HOWEVER, AN AUDIBLE ALARM WAS PRESENT. NO PATIENT HARM OR SERIOUS INJURY WAS REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE REPORTED ISSUE WAS CONFIRMED UPON RECEIPT. DURING TESTING, AC POWER WAS APPLIED AND AN ATTEMPT WAS MADE TO POWER ON THE DEVICE. THE DEVICE FAILED TO POWER ON, EXHIBITING A BLACK SCREEN ACCOMPANIED BY A CONTINUOUS RED ALARM INDICATOR. THE ROOT CAUSE OF THE FAILURE WAS IDENTIFIED AS A CORRUPTED SYSTEM BOARD PRINTED CIRCUIT ASSEMBLY (PCA). THE SYSTEM BOARD PCA WAS REPLACED TO RESOLVE THE ISSUE. ADDITIONALLY, PHYSICAL DAMAGE WAS NOTED, INCLUDING A CRACKED HANDLE AND A MISSING POWER CORD RETAINER. BOTH WERE REPLACED. FOLLOWING THE REPAIR, THE DEVICE PASSED ALL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24815504 ↗
• MalfunctionMar 24, 2026Mechanical Problem; Failure to Calibrate

  A TRILOGY 200 VENTILATOR, U.S.A. - BT WAS RETURNED TO THE MANUFACTURER FOR RECERTIFICATION. THERE WAS NO ALLEGATION OF PATIENT HARM. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. THE TRILOGY 200 DEVICE FAILED THE LEAK TEST STEP DURING EVALUATION AT THE MANUFACTURER¿S SERVICE CENTER. THE ROOT CAUSE WAS DETERMINED TO BE A HOLE IN THE TUBING. THE DEVICE¿S TUBING WAS REPLACED TO ADDRESS THE TEST FAILURE. AFTER THE REPAIR THE DEVICE PASSED ALL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24677205 ↗
• MalfunctionFeb 19, 2026Circuit Failure; Failure to Calibrate; Battery Problem

  A TRILOGY 100 VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF PATIENT HARM. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. THE TRILOGY 100 DEVICE FAILED INTERNAL LI-ION BATTERY TESTS DURING EVALUATION AT THE MANUFACTURER'S SERVICE CENTER. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S INTERFACE BOARD AND INTERNAL BATTERY PACK TO ADDRESS THE ISSUE. ADDITIONALLY, BEFORE THE DEVICE WAS RETURNED TO TECHNICIAN FOR ADDITIONAL EVALUATION DUE TO FAILED REPAIR TEST, THE DEVICE'S MISSING FEET, O-RING, AND CORD RETAINER, DAMAGED PORT BLOCK, REAR AND FRONT ENCLOSURES WERE REPLACED. THE DEVICE ALSO FAILED THE TEST STEP FOR NURSE CALL ON. THE DEVICE WAS DISQUALIFIED FROM RECERTIFICATION. NO REPAIRS COMPLETED. DEVICE WILL BE SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24397175 ↗
• MalfunctionFeb 19, 2026Electrical /Electronic Property Problem; Failure to Calibrate; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT AN ERROR CODE, BATTERY LOW STATE OF HEALTH LITHIUM-ION INTERNAL BATTERY, WAS OBSERVED 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 MANUFACTURER SERVICE CENTER WHEN THE ERROR CODE WAS FOUND ON THE DEVICE. DURING THE EVALUATION IT WAS NOTED THAT THE DEVICES INTERNAL BATTERY HAD FAILED FOR THIS DEVICE. IT WAS CONFIRMED WHEN PERFORMING THE SIGNIFICANT EVENT LOG TEST STEP FAILING ON THE DEVICE. IN ADDITION, THE DEVICE HAD FAILED THE HARDWARE POWER FAIL TEST STEP ON THE DEVICE. THE SERVICE TECHNICIAN EVALUATED BUT WAS NOT ABLE TO IDENTIFY THE CAUSE FOR THIS FAILED TEST STEP. IN CONCLUSION, THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE FRONT AND REAR ENCLOSURE CASES, HANDLE, CORD RETAINER, AND 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 24393340 ↗
• MalfunctionJan 20, 2026Circuit Failure; Failure to Calibrate

  THE MANUFACTURER RECEIVED A TRILOGY 200 DEVICE FOR SERVICE AND PREVENTIVE MAINTENANCE, DURING WHICH SUBSEQUENT REPAIR TESTING IDENTIFIED A FAILURE RELATED TO THE PURGE VALVE (DP PURGE VALVE). THE DEVICE WAS NOT DOCUMENTED AS BEING IN PATIENT USE AT THE TIME OF THE EVENT, AND NO PATIENT HARM OR ADVERSE CLINICAL OUTCOME WAS REPORTED. DURING EVALUATION AND REPAIR TESTING, THE DEVICE FAILED TESTING ASSOCIATED WITH THE PURGE VALVE FUNCTION, AND THE FAILURE WAS CONFIRMED WITH SUPPORTING TEST DOCUMENTATION. FURTHER ASSESSMENT DETERMINED THAT THE SENSOR BOARD CIRCUIT BOARD (PCA), REQUIRED REPLACEMENT DUE TO THE CONFIRMED PURGE VALVE TEST FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24127195 ↗
• MalfunctionJan 12, 2026Mechanical Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY 200 VENTILATOR WAS REPORTED TO HAVE FAILED REPAIR TESTING. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY WAS REPORTED. DURING THE DEVICE EVALUATION, THE VENTILATOR FAILED REPAIR TESTING FOR FAILURE OF THE NULL AND PURGE VALVES. THESE FAILURES INDICATE REPLACEMENT OF THE SENSOR BOARD IS REQUIRED TO ADDRESS THE ISSUE. 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 24042543 ↗
• MalfunctionDec 18, 2025Failure to Calibrate; 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. THE DEVICE WAS NOT IN PATIENT USE. 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 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 PORTING BLOCK PORT WAS FOUND TO BE DAMAGED SO THE UNIVERSAL PORTING BLOCK WAS REPLACED. THE BASE ENCLOSURES WAS FOUND TO BE DAMAGED SO THE BASE ENCLOSURE WAS REPLACED. THE HANDLE O-RING WAS FOUND TO BE MISSING SO THE O-RING WAS INSTALLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23842756 ↗
• MalfunctionDec 18, 2025Failure to Calibrate; 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. THE DEVICE WAS NOT IN PATIENT USE. 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 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 PORTING BLOCK PORT WAS FOUND TO BE PINCHED/DAMAGED SO THE UNIVERSAL PORTING BLOCK WAS REPLACED. THE REAR CASE, FRONT CASE AND BASE ENCLOSURES WERE FOUND DAMAGED SO THEY WERE REPLACED. THE HANDLE WAS FOUND TO BE CRACKED SO THE HANDLE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23842344 ↗
• MalfunctionDec 1, 2025Circuit Failure; Failure to Calibrate; Circuit 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. THE DEVICE WAS NOT IN PATIENT USE. 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, THE DEVICE WAS FOUND TO HAVE MISSING/DISPLACED RUBBER FEET, THE PORTING BLOCK PORT WAS FOUND TO BE PINCHED/DAMAGED AND THE REAR ENCLOSURE WAS FOUND TO HAVE EXTERIOR DAMAGE. ALL PARTS REPLACED TO ADDRESS THE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23683554 ↗
• MalfunctionNov 26, 2025Failure to Calibrate; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE POSITIVE FLOW VERIFY TEST STEP HAD FAILED ON A TRILOGY 100 DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY 100 DEVICE WAS EVALUATED AT THE MANUFACTURER SERVICE CENTER. DURING THE EVALUATION IT WAS NOTED THAT THERE WAS A CALIBRATION OF THE DEVICE THAT HAD CAUSED THIS PARTICULAR TEST CASE TO FAIL ON THE DEVICE. IN CONCLUSION, THE DEVICE WAS RECALIBRATED TO ADDRESS THE ISSUE. THE DEVICE WAS RETESTED AND HAD FAILED THE REPAIR TESTING ON THE DEVICE. PHILIPS IS CURRENTLY INVESTIGATING THIS COMPLAINT. THE DEVICE IS STILL BEING EVALUATED BY THE MANUFACTURER SERVICE CENTER AND IS CURRENTLY AWAITING EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS DUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658860 ↗
• MalfunctionNov 12, 2025Failure to Calibrate; Device Sensing Problem; Failure to Calibrate; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION FROM A PHILIPS SERVICE TECHNICIAN THAT THE POSITIVE FLOW VERIFY TEST STEPS HAD FAILED ON THE TRILOGY 200 DEVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. PHILIPS IS CURRENTLY INVESTIGATING THIS COMPLAINT. THE DEVICE HAS BEEN RECEIVED BY THE (THIRD-PARTY SERVICE CENTER/MANUFACTURER) AND IS CURRENTLY AWAITING EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS DUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535943 ↗
• MalfunctionNov 3, 2025Electrical /Electronic Property Problem; Mechanical Problem; Failure to Calibrate; Battery Problem; Electrical /Electronic Property Problem; Mechanical Problem; Failure to Calibrate; Battery Problem

  THE TRILOGY 100 VENTILATOR WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR PREVENTATIVE MAINTENANCE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION IT WAS NOTED THE DEVICE RETURNED TO THE TECHNICIAN FOR ADDITIONAL EVALUATION DUE TO A CRITICAL ERROR CODE IN RELATION TO (DSP_MOTOR_FAILURE). IN CONCLUSION THE DEVICE INTERNAL BATTERY PACK NEEDS TO BE REPLACED TO RESOLVE THE ISSUE. THERE ARE NO BATTERY PACKS IN STOCK, AND THE UNIT WILL BE PLACED ON WAIT UNTIL THE PART BECOME AVAILABLE. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, COMPONENTS WERE REPLACED AS PART OF COSMETIC OR PHYSICAL DAMAGE OF THE DEVICE UNRELATED TO THE REPORTABLE MALFUNCTION/ISSUE. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23453479 ↗
• MalfunctionNov 3, 2025Mechanical Problem; Failure to Calibrate; Mechanical Problem; Failure to Calibrate

  THE TRILOGY 200 VENTILATOR WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR PREVENTATIVE MAINTENANCE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION IT WAS NOTED THE DEVICE RETURNED TO THE TECHNICIAN FOR ADDITIONAL EVALUATION DUE TO A POSITIVE FLOW VERIFY FAILED REPAIR TEST. THERE WERE NO SIGNIFICANT EVENT(S) IN THE ERROR LOG(S). IN CONCLUSION THE UNIT WAS RECALIBRATED TO RESOLVE THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, COMPONENTS WERE REPLACED: POWER CORD CLAMP, RUBBER FEET WERE MISSING, UNIVERSAL PORTING BLOCK AND HANDLE WERE DAMAGED AND REPAIRED UNRELATED TO THE REPORTABLE MALFUNCTION/ISSUE. THE SOFTWARE WAS UPGRADED TO VERSION: 14.2.05. THE DEVICE PASSED ALL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452764 ↗
• MalfunctionOct 30, 2025Circuit Failure; Electrical /Electronic Property Problem; Failure to Calibrate; Circuit Failure; Electrical /Electronic Property Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY 200 VENTILATOR DID NOT MEET ACCEPTANCE CRITERIA OF EVALUATION PROCESS. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY 200 VENTILATOR WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION IT WAS NOTED THAT THE DEVICE FAILED A TEST STEP DURING TESTING AND WAS RETURNED TO THE TECHNICIAN FOR FURTHER EVALUATION. THERE WERE NO SIGNIFICANT EVENT(S) IN THE ERROR LOG(S). THE ROOT CAUSE ISN'T CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE TECHNICIAN CONFIRMED THE DEVICE MAC ADDRESS LABEL WAS ADDED - ORIGINAL WAS ILLEGIBLE, UNIVERSAL PORTING BLOCK PORT, REAR AND FRONT ENCLOSURE WAS DAMAGED, AND ALL WERE REPLACED UNRELATED TO THE REPORTABLE MALFUNCTION/ISSUE. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426539 ↗
• MalfunctionOct 21, 2025Battery Problem; Battery Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, AN ERROR CODE RELATED TO THE INTERNAL BATTERY WAS OBSERVED. ERR_PERM_FAIL_INT_LI_ION MEANS THERE WAS AN INTERNAL LI-ION BATTERY PERMANENT FAILURE. THE INTERNAL BATTERY PACK NEEDS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, AN URGENT REMINDER ERROR CODE WAS OBSERVED. ERR_URGENT_REMINDER IS A NOTIFICATION TO THE USER THAT ONE OR MORE ¿VENTILATOR SERVICE REQUIRED¿ ERRORS ARE ACTIVE IN THE SYSTEM. THIS IS INFORMATIONAL. ALSO, DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE FRONT CASE ENCLOSURE, REAR CASE ENCLOSURE AND BASE ENCLOSURE ASSEMBLY WERE FOUND TO HAVE DAMAGE AND REPLACED. THE DEVICE WAS FOUND TO HAVE MISSING/DISPLACED RUBBER FEET, ISSUE ADDRESS WITH REPLACEMENT OF BASE ENCLOSURE ASSEMBLY. THE CORD RETAINER WAS FOUND TO BE MISSING/BROKEN, THE CABLE CLAMP WAS REPLACED. THE PORTING BLOCK PORT WAS FOUND TO BE PINCHED/DAMAGED, THE UNIVERSAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23349387 ↗
• MalfunctionJul 16, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER¿S SERVICE CENTER, IT WAS OBSERVED THERE WAS AN ISSUE WITH THE SCREEN ON THIS TRILOGY 200 DEVICE. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE MANUFACTURER'S SERVICE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S LIQUID CRYSTAL DISPLAY (LCD) TO ADDRESS THIS ISSUE. NO REPAIR WAS PERFORMED. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE WERE DAMAGE TO THE PORTING BLOCK AND BASE ENCLOSURE CASE, AND RUBBER FEET MISSING ON THE DEVICE. THE MANUFACTURER'S SERVICE TECHNICIAN RECOMMENDED REPLACING THE RUBBER ENCLOSURE FEET, BASE ENCLOSURE ASSEMBLY, AND THE UNIVERSAL PORTING BLOCK FOR THIS DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22524380 ↗