Trilogy 00 (REF CA1054096)Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00606959022805), received between Feb 17, 2016 and Sep 30, 2026 — classified as 46 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Mechanical Problem; 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 an active exhalation valve during testing. The device's active exhalation control module was replaced to address the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947050 ↗
• MalfunctionMay 5, 2026Circuit Failure; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY 100 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. DURING FUNCTIONAL TESTING, THE DEVICE FAILED A PRESSURE SENSOR CALIBRATION TEST. THE PRINTED CIRCUIT ASSEMBLY (PCA) SENSOR BOARD REQUIRED REPLACEMENT TO CORRECT THE ISSUE. ADDITIONALLY, OBSERVATIONS UNRELATED TO THE REPORTED MALFUNCTION WERE NOTED. THESE INCLUDED MISSING RUBBER FEET AND A MISSING HANDLE O-RING KIT, AS WELL LABEL REPLACEMENT DUE TO A REVISION. 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 25079897 ↗
• MalfunctionApr 2, 2026Circuit Failure; Electrical /Electronic Property Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY 100 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. UPON INSPECTION, THE HUMIDIFIER FEET WERE FOUND TO BE MISSING, AND THE ENCLOSURE SEAL KIT EXHIBITED PHYSICAL DAMAGE. DURING FUNCTIONAL TESTING, THE DEVICE INITIALLY FAILED THE NURSE CALL ON/OFF TEST. THIS FAILURE WAS ATTRIBUTED TO OPERATOR ERROR, AS THE REQUIRED ADAPTER FOR THE NURSE CALL TEST WAS NOT USED. THE DEVICE WAS RETESTED WITH THE APPROPRIATE ADAPTER AND SUBSEQUENTLY PASSED. THE DEVICE ALSO FAILED THE RED ALARM LED TEST, WHICH VERIFIES PROPER LED FUNCTION DURING ALARM CONDITIONS. DEVICE LOG FILES WERE SUCCESSFULLY DOWNLOADED AND REVIEWED. A ¿VENTILATOR SERVICE REQUIRED¿ ERROR WAS IDENTIFIED, INDICATING A FAILURE ASSOCIATED WITH THE SYSTEM PCA¿CPU DAUGHTER CARD VPOWERFAIL CIRCUIT. THE PRINTED CIRCUIT ASSEMBLY (PCA) WAS REPLACED TO CORRECT THIS ISSUE. FOLLOWING REPAIR, THE DEVICE SUCCESSFULLY PASSED ALL REQUIRED TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24764464 ↗
• MalfunctionFeb 25, 2026Failure to Calibrate; Battery Problem

  A TRILOGY 100 WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO EVIDENCE THE DEVICE WAS IN PATIENT USE. DURING THE EVALUATION, THE DEVICE FAILED THE SIGNIFICANT EVENT LOG TEST STEP FOR A SERVICE REQUIRED ALARM CONDITION INDICATING THE INTERNAL BATTERY WAS NOT FUNCTIONING TO SPECIFICATION. THE INTERNAL BATTERY NEEDS TO BE REPLACED. A FINAL REPORT IS BEING FILED. IF NEW INFORMATION BECOMES AVAILABLE FOLLOWING THE COMPLETION OF THE DEVICE REPAIR THAT CHANGES THE OUTCOME OF THE INVESTIGATION, A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24445632 ↗
• MalfunctionFeb 13, 2026Mechanical Problem; Failure to Calibrate

  A TRILOGY 100 VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING EVALUATION OF THE DEVICE AT THE MANUFACTURER SERVICE CENTER, THE DEVICE FAILED AN 'ACTIVE EXHALATION PROPORT VALVE OPEN' TEST. THE SERVICE TECHNICIAN STATES THAT THE ACTIVE EXHALATION CONTROL MODULE (AECM) VALVE NEEDS TO BE REPLACED TO RESOLVE THE ISSUE. A REPAIR ESTIMATE IS AWAITING CUSTOMER APPROVAL IN ORDER TO PROCEED WITH THE REPAIR. ADDITIONALLY, THE FEET, PORTING BLOCK, POWER CORD CLAMP, BASED ENCLOSURE, AND ENCLOSURE GASKET WERE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24340106 ↗
• MalfunctionNov 17, 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. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE RUBBER FEET WERE REPLACED DUE TO MISSING ON THE DEVICE. THIS WAS UNRELATED TO THE REPORTABLE MALFUNCTION/ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23578033 ↗
• MalfunctionJul 10, 2024Degraded; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING VISUALIZATION BLACK PARTICULATES ON THE N95 FILTER DURING CIRCUIT CHANGE. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. 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 19709681 ↗
• MalfunctionMar 17, 2022Degraded; Degraded

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. 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'S INLET AIR PATH ASSEMBLY AND REMOVABLE AIR PATH FOAM WERE REPLACED DUE TO PREVENTATIVE MAINTENANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13801093 ↗
• MalfunctionMar 10, 2022Degraded; Degraded

  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'S POLLEN FILTER AND ULTRA FINE FILTER WERE REPLACED DUE TO CONTAMINATION. 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 13725537 ↗
• MalfunctionDec 28, 2021Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A VENTILATOR'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. 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 13095167 ↗
• MalfunctionMay 12, 2021Mechanical Problem; Mechanical 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, AN ISSUE RELATED TO THE ACTIVE EXHALATION CONTROL MODULE WAS OBSERVED. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11810966 ↗
• MalfunctionApr 27, 2021Failure to Charge; Battery Problem; Failure to Charge; Battery 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, AN ERROR CODE RELATED TO THE CHARGING OF THE INTERNAL BATTERY WAS OBSERVED. THE DEVICE'S INTERNAL BATTERY NEEDS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11731494 ↗
• MalfunctionMar 10, 2021Failure to Charge; Battery Problem; Failure to Charge; Battery Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTIVE MAINTENANCE. 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, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S INTERNAL BATTERY NEEDS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11455062 ↗
• MalfunctionFeb 3, 2021Failure to Charge; Battery Problem; Failure to Charge; Battery Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. 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, AN ERROR CODE RELATED TO THE CHARGING OF THE INTERNAL BATTERY WAS OBSERVED. THE DEVICE'S INTERNAL BATTERY NEEDS TO BE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11272745 ↗
• MalfunctionJan 14, 2021Failure to Charge; Failure to Power Up; Battery Problem; Insufficient Device Problem Information; Failure to Charge; Failure to Power Up; Battery Problem; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED TO POWER ON. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 11170349 ↗
• MalfunctionJan 6, 2021Unexpected Shutdown; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS SHUTTING DOWN. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION BY 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 11124441 ↗
• MalfunctionDec 1, 2020Computer Software Problem; Computer Software Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTIVE MAINTENANCE. 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, A "VENTILATOR INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SOFTWARE WAS RELOADED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10929575 ↗
• MalfunctionApr 22, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. 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, A FAILURE OF THE LCD SCREEN WAS OBSERVED. THE DEVICE'S LCD SCREEN WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 8536695 ↗
• MalfunctionApr 5, 2019Battery Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S INTERNAL BATTERY WAS FAULTY. THE DEVICE WAS NOT IN PATIENT USE. 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 INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 8487960 ↗
• MalfunctionFeb 19, 2019Power Problem; Power Problem

  A VENTILATOR WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE VENTILATOR AT THE THIRD PARTY SERVICE CENTER, THE VENTILATOR FAILED TO POWER ON WITHOUT AC POWER. THE DEVICE'S POWER MANAGEMENT BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8350943 ↗
• MalfunctionJan 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WOULD NOT POWER ON FOLLOWING TESTING. THE MANUFACTURER IS CURRENTLY INVESTIGATING THIS EVENT AND A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

  Patient problems: No Patient Involvement

  MAUDE report 8236111 ↗
• MalfunctionDec 31, 2018No Display/Image; Failure to Power Up; No Display/Image; Failure to Power Up

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S LCD SCREEN WAS BLANK AFTER RETURNING FOR PREVENTATIVE MAINTENANCE. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 Patient Involvement

  MAUDE report 8206415 ↗
• MalfunctionNov 7, 2018Failure to Charge; Battery Problem; Failure to Charge; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S INTERNAL BATTERY FAILS TO HOLD A CHARGE. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8046576 ↗
• MalfunctionSep 12, 2018Failure to Charge; Battery Problem; Failure to Charge; Battery Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. 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, ERROR CODES RELATED TO THE CHARGING OF THE INTERNAL BATTERY WERE OBSERVED. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUES.

  Patient problems: No Patient Involvement

  MAUDE report 7868154 ↗
• MalfunctionAug 22, 2018Failure to Power Up; Failure to Power Up

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WOULD NOT POWER ON. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7804508 ↗

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-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-0884-2023 · Dec 7, 2022 · Open, Classified
  Philips Garbin Ventilator, Model Number 1058180B
• 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