Trilogy Trilogy100 Ventilator, United StatesRecalls & reported problems

Summary

The FDA's MAUDE database contains 8,161 adverse event reports that list this exact device (DI 00606959015364), received between Sep 23, 2015 and Sep 30, 2026 — classified as 92 deaths, 154 injuries, 7,904 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (2,220 reports).

8 other recalls cover devices cleared under the same FDA submission (K083526); they may or may not involve this specific model.

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 8,161 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949245 ↗
• MalfunctionSep 30, 2026Failure to Power Up

  The manufacturer received information that a Trilogy100 Ventilator, U.S.A. device had no power. There was no patient involvement, and no harm or injury reported.There were no visible foam particles in the device on evaluation. The device evaluation does not identify any specific component malfunction that would need to be replaced to resolve the no power issue. The device was scrapped.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946410 ↗
• MalfunctionSep 29, 2026Electrical /Electronic Property Problem; Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940636 ↗
• MalfunctionSep 29, 2026Battery Problem

  The manufacturer received information that a Trilogy 100 ventilator was returned to a third-party service center for evaluation. There was no patient involvement, and no harm or injury reported.During the device evaluation, a critical, high-priority ventilator service required error code 199- ERR_VLI_ION_FAILURE was noted in the device error log indicating a failure that affects the communication to the batteries and the selection of the power sources. No visible foam particles were noted in the device. No repair was completed on the device; the device was processed as scrap and discarded per local regulations.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934118 ↗
• MalfunctionSep 28, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917562 ↗
• MalfunctionSep 25, 2026Circuit Failure; Failure to Calibrate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902903 ↗
• MalfunctionSep 25, 2026Degraded

  A Trilogy 100 ventilator was returned to a third-party service center in reference to the voluntary Field Safety Notice/recall notification related to the sound abatement foam in certain CPAP, BiPAP, and mechanical ventilator devices. There was no report of patient harm or injury.During the evaluation at the third-party service center, the device was visually inspected, and foam particles were observed. The device was remediated, and the foam insulation needs to be replaced to resolve the issue. The device will be scrapped; therefore, no additional repair information was provided. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899198 ↗
• MalfunctionSep 25, 2026Electrical /Electronic Property Problem

  A Trilogy 100 ventilator was returned to the third-party service center in reference to the voluntary Field Safety Notice/recall notification related to the sound abatement foam in certain CPAP, BiPAP, and mechanical ventilator devices. There was no allegation of serious or permanent harm or injury. During the evaluation of the device at a third-party service center, the device was visually inspected and found no evidence of foam degradation. However, during the evaluation it was noted that an error code, LOSS_OF_COMM_INT_LI_ION, was observed on the device's error log. Device logs were not available; therefore, the date of the most recent error codes occurrence could not be determined. At this time, the reported error code event date is based solely on the customer's information received. The root cause was not confirmed. No repairs were performed and the device will be scrapped.Additionally, the evaluation of the device data identified an unrelated error code. This error code is consistent with normal device operation and expected use conditions and is not considered reportable under medical device reporting requirements. No evidence was identified to suggest that the error code c

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898323 ↗
• MalfunctionSep 25, 2026Display or Visual Feedback Problem; Failure to Calibrate

  A Trilogy 100 was returned to a third-party service center for evaluation. There was no harm or injury reported. There was no evidence that the device was in patient use. During the evaluation, the test failed the LCD screen test. In conclusion, the LCD kit was replaced. The unit passed the functional test.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896611 ↗
• MalfunctionSep 24, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890313 ↗
• MalfunctionSep 24, 2026Electrical /Electronic Property Problem; Battery Problem

  The manufacturer received information alleging a Trilogy 100 was alarming for a service required alarm condition. There was no harm or injury reported. The device was not in patient use. The device was returned to the manufacturer's service center and the customer's complaint was confirmed. A service required alarm indicating an internal battery capacity was less than 51% was observed in the device's downloaded event log. The device logs were not available; therefore, the date of the most recent error codes occurrence could not be determined. At this time, the reported error code event date is based solely on the customer's information received and has not been confirmed through device evaluation. The device's internal battery needs to be replaced. No repairs have been completed as the service center is awaiting component delivery. 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 50886543 ↗
• MalfunctionSep 24, 2026Electrical /Electronic Property Problem

  A Trilogy100 Ventilator, U.S.A. device was returned to a third-party service center for evaluation. There was no allegation of device malfunction, and the device was not reported to have been in patient use.During evaluation of the device, the service technician confirmed that error ERR_PERM_FAIL_INT_LI_ION (error code 193) was found in the device error code log. The device evaluation does not identify any specific component malfunction that would need to be replaced to resolve this error code.Additionally, the service technician noted that there were no visible foam particles. After the evaluation was complete, the device was scrapped.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882467 ↗
• MalfunctionAug 31, 2026Electrical /Electronic Property Problem; Power Problem

  A Trilogy 100 ventilator was returned to the third-party service center in reference to the voluntary Field Safety Notice / recall notification related to the sound abatement foam in certain CPAP, BiPAP, and mechanical ventilator devices. There was no allegation of serious or permanent harm or injury. During the evaluation of the device at a third-party service center, the device was visually inspected and found no evidence of foam degradation. However, a No Power condition occurred. No repairs were performed and the device will be scrapped.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50526508 ↗
• MalfunctionAug 27, 2026Electrical /Electronic Property Problem

  A Trilogy 100 was returned to a third-party service center for evaluation. There was no harm or injury reported. There was no evidence the device was in patient use. During the evaluation a ventilator inoperative alarm condition indicating a motor failure was noted. The device logs were not available; therefore, the date of the most recent error codes occurrence could not be determined. At this time, the reported error code event date is based solely on the customer's information received and has not been confirmed through device evaluation. There was no documentation of any components replaced for this issue. There was no foam particles observed. No repairs were performed. The device was scrapped.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50478194 ↗
• MalfunctionAug 27, 2026Degraded; Battery Problem

  A Trilogy 100 was returned to a third-party service center for evaluation. 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 failure was observed in the device's downloaded event log. There was no documentation of any components replaced for this issue. During the evaluation of the device, it was visually inspected and found evidence of foam degradation. No repairs were performed. The device was scrapped.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50478188 ↗
• MalfunctionAug 27, 2026Battery Problem

  A Trilogy 100 was returned to a third-party service center for evaluation. There was no harm or injury reported. There was no evidence the device was in patient use. During the evaluation, an error related to an internal battery failure was observed. There was no documentation of any components replaced for this issue. There was no foam particles observed. No repairs were performed. The device was scrapped.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50473951 ↗
• MalfunctionAug 27, 2026Battery Problem

  A Trilogy 100 was returned to a third-party service center for evaluation. There was no harm or injury reported. There was no evidence the device was in patient use. During the evaluation, an error related to an internal battery failure was observed. There was no documentation of any components replaced for this issue. There was no foam particles observed. No repairs were performed. The device was scrapped.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50473939 ↗
• MalfunctionAug 25, 2026Battery Problem

  The manufacturer received information that a Trilogy 100 ventilator was returned to a third-party service center for evaluation. There was no patient involvement, and no harm or injury reported.On device evaluation, a ventilator service required alarm was noted in the device log indicating an internal battery fault. This is the final power source so it may impact therapy. No device repair was completed; the device was processed as scrap and discarded per local regulations.Additional findings not related to the malfunction/issue: The SD card slot was noted to be damaged, and the speakers were not plugged in.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50427510 ↗
• MalfunctionAug 13, 2026Thermal Decomposition of Device

  A Trilogy 100 Ventilator, U.S.A. device was returned to the manufacturer for evaluation with no initial alleged complaint.During the evaluation at the manufacturer's Product Investigation Laboratory (PIL), the service technician confirmed that a thermal event occurred but could not determine the cause of the thermal event.Additionally, the Device SN/MN label had to be added since the original had the incorrect GTIN/revision. The device is being forwarded back to the customer via Service. A final report is being filed, if additional information is received that changes the outcome of the investigation and associated coding, a supplemental report will be filed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50239311 ↗
• MalfunctionJul 30, 2026Battery Problem

  A Trilogy 100 was returned to a third-party service center for evaluation. There was no harm or injury reported. There was no evidence the device was in patient use. During the evaluation a service required alarm indicating an internal battery was not present was observed in the downloaded event log. There was no documentation of any components replaced for this issue. No foam particles were observed. No repairs were performed. The device was scrapped.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50081706 ↗
• MalfunctionJun 30, 2026Electrical /Electronic Property Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY 100 VENTILATOR WAS RETURNED FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE WAS EVALUATED AT A THIRD-PARTY SERVICE CENTER. INITIAL INSPECTION IDENTIFIED MULTIPLE ISSUES, INCLUDING MISSING RUBBER FEET AND A MISSING HANDLE O-RING KIT. IN ADDITION, THE EXHALATION PORT BLOCK, HANDLE KIT, BASE ENCLOSURE KIT, REAR ENCLOSURE ASSEMBLY, AND FRONT CASE WERE FOUND TO BE CRACKED. THE ENCLOSURE SEAL KIT NEEDED TO BE REPLACED DUE TO A CHANGE IN THE REAR ENCLOSURE AND THE WARNING LABEL DOM KIT REQUIRED REPLACEMENT DUE TO A CHANGE IN THE BASE ENCLOSURE. ADDITIONALLY, THE THTPOL LABEL REQUIRED REPLACEMENT DUE TO UNACCEPTABLE REVISION. DURING FUNCTIONAL TESTING, THE DEVICE FAILED THE INTERNAL BATTERY CAPACITY TEST. THIS TEST VERIFIES THAT THE BATTERY IS CHARGED TO A PARTICULAR LEVEL REQUIRED FOR TESTING AND DOES NOT IMPACT THERAPY DELIVERY. REVIEW OF THE ERROR LOGS FOLLOWING REPAIR TEST IDENTIFIED A "VENT SERVICE REQUIRED" ALARM ASSOCIATED WITH AN INTERNAL LI-ION BATTERY PERMANENT FAILURE. AN ADDITIONAL ERROR INDICATING A BATTERY CELL UNDER-VOLTAGE CONDITION WITHIN THE BATTERY PACK WAS ALSO OBSERV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25668568 ↗
• MalfunctionJun 30, 2026Circuit Failure; Mechanical Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY 100 VENTILATOR WAS RETURNED FOR SERVICE. NO PATIENT HARM OR INJURY WAS REPORTED. THE DEVICE WAS EVALUATED AT A THIRD-PARTY SERVICE CENTER. DURING THE EVALUATION, THE POWER CORD CLAMP AND RUBBER FEET WERE FOUND TO BE MISSING. THE HANDLE KIT, BASE ENCLOSURE KIT, REAR ENCLOSURE ASSEMBLY, EXHALATION PORT BLOCK PAS, AND FRONT CASE KIT WERE OBSERVED TO BE CRACKED, AND THE TOP PLATE ENCLOSURE KIT WAS FOUND TO BE BROKEN. DUE TO REPLACEMENT OF THE REAR ENCLOSURE, THE ENCLOSURE SEAL KIT AND PORTING BLOCK ADAPTER KIT WERE ALSO REPLACED. REPLACEMENT OF THE INTERFACE PRINTED CIRCUIT ASSEMBLY (PCA) KIT, WARNING LABEL KIT, AND THTPOL LABEL WAS REQUIRED DUE TO REPLACEMENT OF THE BASE ENCLOSURE. IN ADDITION, TOBACCO RESIDUE CONTAMINATION WAS OBSERVED IN THE FILTER AND TUBING ASSEMBLY. FUNCTIONAL TESTING WAS PERFORMED, DURING WHICH THE DEVICE FAILED THE HARDWARE POWER FAIL (HW POWER FAIL) TEST. FURTHER EVALUATION DETERMINED THAT THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) REQUIRED REPLACEMENT TO ADDRESS THE FAILURE. FOLLOWING REPLACEMENT OF THE SYSTEM PCA, THE DEVICE WAS RETESTED AND SUBSEQUENTLY FAILED THE ACTIVE EXHALATION PROPORTIONAL VALVE TEST. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25663776 ↗
• MalfunctionJun 29, 2026Circuit Failure; Electrical /Electronic Property Problem

  A TRILOGY100 VENTILATOR USA WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY ASSOCIATED WITH THIS EVENT. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE AT THE TIME OF SERVICE. DURING EVALUATION AT THE THIRD-PARTY SERVICE CENTER, REVIEW OF THE DEVICE EVENT LOG IDENTIFIED ERR_VPWRFAIL_OSCILATING_FAILURE, INDICATING A U24 OR U26 CIRCUITRY FAILURE ON THE SYSTEM BOARD OR CPU DAUGHTER BOARD AND LOSS OF V POWER FAIL, AS WELL AS ERR_VPWRFAIL_FAILURE RELATED TO THE SYSTEM PCA-CPU DAUGHTER CARD V POWER FAIL CIRCUIT. THE REPORTED ISSUE WAS CONFIRMED DURING INVESTIGATION. TO ADDRESS THESE CONDITIONS, THE SYSTEM BOARD AND CENTRAL PROCESSING UNIT BOARD ASSEMBLY WERE REPLACED. IN ADDITION, SEVERAL COMPONENTS WERE IDENTIFIED AS PHYSICALLY DAMAGED AND/OR MISSING AND REQUIRED REPLACEMENT. THESE CONDITIONS WERE DETERMINED NOT TO AFFECT PATIENT THERAPY. FOLLOWING REPAIR, THE DEVICE SUCCESSFULLY PASSED FUNCTIONAL TESTING AND MET SPECIFICATION REQUIREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25659126 ↗
• MalfunctionJun 29, 2026Electrical /Electronic Property Problem; Battery Problem

  A TRILOGY100 VENTILATOR, U.S.A. DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO ALLEGATION OF PATIENT HARM. DURING THE EVALUATION, THE DEVICE FAILED THE FUNCTIONAL TEST FOR ERROR ERR_PERM_FAIL_INT_LI_ION (ERROR CODE 193) AND ERROR ERR_TDA_CELL_UNDER_VOLTAGE_INT_BATTERY_LOG _ONLY (ERROR CODE 210). FROM THIS FAILED TEST, THE INTERNAL BATTERY PACK WAS FOUND TO BE DAMAGED AND WAS REPLACED. ADDITIONALLY, THE EVALUATION OF THE DEVICE DATA IN THE FUNCTIONAL TEST IDENTIFIED UNRELATED ERROR CODES. THESE ERROR CODES ARE CONSISTENT WITH NORMAL DEVICE OPERATION AND EXPECTED USE CONDITIONS AND ARE NOT CONSIDERED REPORTABLE UNDER MEDICAL DEVICE REPORTING REQUIREMENTS. NO EVIDENCE WAS IDENTIFIED TO SUGGEST THAT THESE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. THE DEVICE ALSO FAILED THE CHECK INTERNAL BATTERY CAPACITY TEST STEP. THE SERVICE TECHNICIAN ALSO NOTED THAT THE TRILOGY HANDLE KIT WAS CRACKED, THE BASE ENCLOSURE WAS CRACKED, THE RUBBER FEET WERE MISSING, AND THE DC POWER CONNECTOR CABLE WAS DAMAGED; ALL OF WHICH WERE REPAIRED TO ADDRESS THE ISSUES. AFTER THE EVALUATION AND REWORK WERE COMPLETE, THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25653521 ↗
• MalfunctionJun 29, 2026Circuit Failure; Failure to Calibrate

  A TRILOGY 100 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 A POWER FAILURE DURING TESTING. THE DEVICE'S SYSTEM BOARD W/ DAUGHTER BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25651427 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083526. One submission often covers many models, so check the product and lot details in each record.

• Z-0884-2023 · Dec 7, 2022 · Open, Classified
  Philips Garbin Ventilator, Model Number 1058180B
• Z-0882-2023 · Dec 7, 2022 · Open, Classified
  Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260, RSL1054260, CA1054096, R1054260B, R1054655
• Z-1956-2021 · Jun 14, 2021 · Open, Classified
  Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
• Z-1065-2016 · Jan 18, 2016 · Terminated
  Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continuous or intermittent ventilatory su
• Z-1143-2014 · Feb 11, 2014 · Terminated
  Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilog
• Z-2024-2012 · Apr 27, 2012 · Terminated
  Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or intermittent ventilatory support for the care of individuals who require m
• Z-0296-2012 · Oct 11, 2011 · Terminated
  Trilogy 100, 200 and 202 Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used fo
• Z-1896-2010 · Jun 10, 2010 · Terminated
  Trilogy 100 Ventilator, Model/Catalog Number 1054260, U1054260 (Domestic). Philips Respironics, Monroeville, PA 15146. Provides continuous or intermittent ventilatory support for