Trilogy 200 Trilogy 200 Ventilator, Italy, BluetoothRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00606959042926), received between Jun 4, 2024 and Jun 10, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (4 reports).

5 other recalls cover devices cleared under the same FDA submission (K093416); 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2026Circuit Failure; Failure to Calibrate; Charging Problem

  A TRILOGY 200 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 THE DEVICE FAILED A TEST STEP INDICATING AN INTERNAL BATTERY CHARGE FAILURE. THE DEVICE'S POWER MANAGEMENT BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. NO COMPONENTS WERE REPLACED. THE DEVICE WAS RETURNED UNREPAIRED AS PER THE CUSTOMER'S REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25460754 ↗
• MalfunctionApr 29, 2026Computer Software Problem

  A DEVICE WAS RETURNED TO A 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. A TRILOGY 200 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR FOAM REMEDIATION ON THE DEVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED FOR A DP CALIBRATION TEST STEP. THERE WAS NO FAILED TEST SHEET AVAILABLE FOR REVIEW. A REPAIR TEST WAS PERFORMED TO FIX THIS TEST FAILURE. THE SOUND ABATEMENT FOAM WAS REPLACED PREVENTATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034453 ↗
• MalfunctionApr 15, 2026Calibration Problem

  A DEVICE WAS RETURNED TO A SERVICE A TRILOGY 200 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR FOAM REMEDIATION ON THE DEVICE. THERE WAS NO HARM OR INJURY REPORTED. 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, THE DEVICE FAILED TEST STEPS RELATED TO (POSITIVE FLOW VERIFY, ZERO FLOW VERIFY, AND NEGATIVE FLOW VERIFY). THE DEVICE WAS UPDATED, AND THE SENSOR TABLE WAS RESET TO RESOLVE THE ISSUE. THE SOUND ABATEMENT FOAM WAS REPLACED PREVENTATIVELY. ADDITIONALLY, DURING THE EVALUATION THERE WERE NO REPORTABLE ERROR CODES FOUND IN THE DEVICE EVENT LOG. THE HANDLE O RING WAS DAMAGED AND WAS REPLACED. THE SOFTWARE WAS UPGRADED. THIS DEVICE HAS BEEN SERVICED, INSPECTED, TESTED, AND MET ACCEPTANCE CRITERIA IN ACCORDANCE WITH ALL OF 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. CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24884483 ↗
• MalfunctionApr 11, 2026Calibration Problem

  A DEVICE WAS RETURNED TO A 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. A TRILOGY 200 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR FOAM REMEDIATION ON THE DEVICE. THERE WAS NO HARM OR INJURY REPORTED. 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, THE DEVICE FAILED A TEST STEP RELATED TO (ACTIVE EXHALATION PURGE VALVE CLOSED AND ACTIVE EXHALATION PROPORTIONAL VALVE OPEN).THE SOUND ABATEMENT FOAM WAS REPLACED PREVENTATIVELY. THE DEVICE CAME ONLY FOR REMEDIATION AND WILL BE RETURNED TO THE CUSTOMER UNREPAIRED. ADDITIONALLY, DURING THE EVALUATION THERE WERE NO REPORTABLE ERROR CODES FOUND IN THE DEVICE EVENT LOG. DUST WAS CONFIRMED ON THE BLOWER BOX. THE HANDLE O RING WAS DAMAGED AND NEEDS TO BE REPLACED. THE SOFTWARE WAS UPGRADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24851992 ↗
• MalfunctionApr 9, 2026Calibration Problem

  A DEVICE WAS RETURNED TO A 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. A TRILOGY 100 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR FOAM REMEDIATION ON THE DEVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED THE ACTIVE EXHALATION PURGE VALVE OPEN AND LOW O2 FLOW TEST STEPS. THE DEVICE WAS REQUESTED TO RETURN UNREPAIRED TO THE CUSTOMER. THE SOUND ABATEMENT FOAM WAS REPLACED PREVENTATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24831533 ↗
• MalfunctionApr 7, 2026Mechanical Problem; Calibration Problem

  A DEVICE WAS RETURNED TO A 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. A TRILOGY 200 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR FOAM REMEDIATION ON THE DEVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THERE WERE NO FOAM PARTICLES FOUND IN THE DEVICE. THE DEVICE FAILED FUNCTIONAL TESTING RELATING TO THE CONTROL PRESS VERIFICATION TEST STEP. THE SERVICE TECHNICIAN STATES THAT THE UNIVERSAL PORTING BLOCK WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE PASSED FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24802038 ↗
• MalfunctionMar 26, 2026Electrical /Electronic Property Problem; Battery Problem

  A DEVICE WAS RETURNED TO A 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. A TRILOGY 200 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR FOAM REMEDIATION ON THE DEVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, A SERVICE REQUIRED ALARM CONDITION INDICATING THE INTERNAL BATTERY WAS IN A LOW STATE OF HEALTH WAS OBSERVED IN THE DEVICE'S DOWNLOADED EVENT LOG. THE INTERNAL BATTERY NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS REQUESTED TO RETURN UNREPAIRED TO THE CUSTOMER. THE SOUND ABATEMENT FOAM WAS REPLACED PREVENTATIVELY. THE CAPA PROCESS IDENTIFIED COMPLAINTS NOT BEING CREATED FOR QUALITY ISSUES FOUND DURING THIRD PARTY SERVICING. BASED ON A REVIEW OF RECORDS IMPACTED BY THE IDENTIFIED ISSUE, IT WAS DETERMINED THAT THIS RECORD NEEDED TO BE CORRECTED AND IS NOW BEING SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700047 ↗
• MalfunctionMar 4, 2026Degraded

  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. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE, FOAM PARTICLES WERE OBSERVED. ADDITIONALLY, THERE IS DUST ON THE BLOWER BOX, THE PATIENT¿S COMPLAINT WAS CONFIRMED, AND THE DEVICE WAS CORRECTED. DUE TO AN ERROR CODE CHECK TUBING. ADDITIONAL REPAIRS NEEDED: KEYPAD IS OVER-USED. MISSING RUBBER FEET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24508078 ↗
• MalfunctionJul 24, 2025Degraded; Degraded

  A DEVICE 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 HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. REMEDIATION AND REPAIR WERE COMPLETED. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: THE RUBBER FEET WERE MISSING AND REQUIRED REPLACEMENT, THE KEYPAD WAS NOTED TO HAVE BEEN OVER-USED, THERE WAS DUST CONTAMINATION OF THE BLOWER BOX NOTED AND CORROSION OF THE DEVICE DATA MODULE WHICH REQUIRED REPLACEMENT OF THE INTERFACE PRINTED CIRCUIT BOARD ASSEMBLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586206 ↗
• MalfunctionJul 22, 2025Degraded; Degraded

  THE DEVICE WAS EVALUATED 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 IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE IS NOT REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE, AT A THIRD-PARTY SERVICE CENTER THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, THE TYPE OF CONTAMINATION HAS BEEN DOCUMENTED AS DUST ON THE BLOWER BOX. ADDITIONALLY, AN ERROR INDICATING THE DETACHABLE BATTERY IS CONNECTED BUT THE DEVICE DOES NOT RECOGNIZE THE CONNECTION WAS OBSERVED. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S DETACHABLE BATTERY TO ADDRESS THE ISSUE. THE DEVICE'S MISSING RUBBER FEET AND O-RINGS REQUIRE REPLACEMENT. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22565423 ↗
• MalfunctionMar 21, 2025Degraded; Degraded

  A TRILOGY 200 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO SERIOUS HARM OR INJURY REPORTED. THERE WAS NO ALLEGATION AGAINST THE DEVICE. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, VISIBLE FOAM PARTICLES WERE NOTED IN THE AIRPATH. THE DEVICES SOUND ABATEMENT FOAM WAS REPLACED TO ADDRESS THIS ISSUE. THE DEVICE'S POLLEN FILTER WAS REINSTALLED INTO THE AIRPATH ASSEMBLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21664044 ↗
• MalfunctionSep 24, 2024Battery Problem; Battery Problem

  A TRILOGY 200 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, ERRORS CODES RELATED TO THE INTERNAL BATTERY WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG INDICATED A DEPLETED BATTERY. ON TESTING, THE BATTERY WAS NOT ABLE TO HOLD A CHARGE. THE INTERNAL LI-ION BATTERY NEEDS REPLACED TO ADDRESS THE ISSUE. UNRELATED TO THE DEPLETED INTERNAL BATTERY ISSUE, THE VENTILATOR WAS MISSING RUBBER FEET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297402 ↗
• MalfunctionJun 4, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  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 THIRD-PARTY SERVICE CENTER, DAMAGE TO THE LIQUID CRYSTAL DISPLAY (LCD) WAS FOUND ON THE DEVICE. THE MANUFACTURER'S INVESTIGATING IS ON-GOING. 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 19464121 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093416. One submission often covers many models, so check the product and lot details in each record.

• Z-0883-2023 · Dec 7, 2022 · Open, Classified
  Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, 1032800, R1032804TP, R1032804B, R1032804TPV, 1032804B
• 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