Trilogy Trilogy EC, U.S.ARecalls & reported problems
Respironics, Inc. · Trilogy EC Ventilator, USA · Class 2
All models of Philips Trilogy Ventilator (90) · Trilogy (46)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00606959022058), received between Oct 8, 2015 and Mar 31, 2025 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Battery Problem” (7 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Battery Problem7
- Failure to Charge5
- Appropriate Device Problem Term/Code Not Available3
- Device Displays Incorrect Message3
- Device Operational Issue2
- Incorrect Or Inadequate Test Results2
- Degraded1
- No Display/Image1
Patient problems
- No Patient Involvement12
- No Consequences Or Impact To Patient5
- No Clinical Signs, Symptoms or Conditions2
- Dizziness1
- Eye Irritation1
- Headache1
- Hypersensitivity/Allergic reaction1
- Nausea1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2025Battery Problem; 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 INTERNAL BATTERY WAS OBSERVED IN THE DEVICE'S EVENT LOG. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE SERVICE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S INTERNAL BATTERY TO ADDRESS THE ISSUE. NO REPAIR WAS PERFORMED. THE DEVICE IS NOT NEEDED FOR INVENTORY AND WAS SCRAPPED. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21732558 ↗MalfunctionJun 17, 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 EYE IRRITATION, NOSE IRRITATION, RESPIRATORY TRACT IRRITATION, DIZZINESS AND/OR HEADACHE, HYPERSENSITIVITY, NAUSEA/VOMITING. THERE WAS NO REPORT OF MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.
Patient problems: Dizziness; Eye Irritation; Headache; Hypersensitivity/Allergic reaction; Nausea; Unspecified Respiratory Problem; Vomiting
MAUDE report 19547947 ↗MalfunctionMar 1, 2021Battery Problem; 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 WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11392652 ↗MalfunctionSep 25, 2018Failure to Charge; Failure to Charge
A VENTILATOR WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR EVALUATION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE VENTILATOR AT THE THIRD PARTY SERVICE CENTER, A FAILURE OF THE DEVICE TO CHARGE IT'S INTERNAL BATTERY WAS OBSERVED. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Patient Involvement
MAUDE report 7905473 ↗MalfunctionApr 10, 2018Failure to Charge; Failure to Charge
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, 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 Consequences Or Impact To Patient
MAUDE report 7411371 ↗MalfunctionFeb 14, 2018Device Operational Issue; Device Operational Issue
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 "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 Consequences Or Impact To Patient
MAUDE report 7269494 ↗MalfunctionFeb 7, 2018Device Displays Incorrect Message; Device Displays Incorrect Message
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A "SERVICE REQUIRED" ALARM CONDITION OCCURRED. THE DEVICE WAS NOT IN PATIENT USE. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND AN ERROR CODE RELATED TO THE CHARGING OF THE INTERNAL BATTERY WAS OBSERVED. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7247400 ↗MalfunctionMay 15, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results
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, THE DEVICE FAILED A STEP DURING TESTING. THE DEVICE'S SENSOR BOARD WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6566448 ↗MalfunctionMar 29, 2017Failure to Charge; Incorrect Or Inadequate Test Results; Device Operational Issue; Failure to Charge; Incorrect Or Inadequate Test Results; Device Operational Issue
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED TO CHARGE ITS INTERNAL BATTERY. THE DEVICE WAS NOT IN PATIENT USE. 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. 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 AND THE DEVICE FAILED TEST STEPS DURING TESTING. THE DEVICE'S POWER MANAGEMENT BOARD AND SENSOR BOARD WERE REPLACED TO ADDRESS THE ISSUES.
Patient problems: No Patient Involvement
MAUDE report 6442270 ↗MalfunctionMar 29, 2017Battery Problem; Battery Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR HAD A FAILURE OF ITS INTERNAL BATTERY. 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 WAS REPLACED TO ADDRESS THE ISSUE. AN ERROR CODE RELATED TO THE POWER MANAGEMENT BOARD WAS OBSERVED. THE DEVICE'S POWER MANAGEMENT BOARD WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Patient Involvement
MAUDE report 6442226 ↗MalfunctionMar 29, 2017Device Displays Incorrect Message; Battery Problem; Device Displays Incorrect Message; Battery Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR "SERVICE REQUIRED" ALARM CONDITION OCCURRED AND A FAILURE OF ITS INTERNAL BATTERY. 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 WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Patient Involvement
MAUDE report 6442203 ↗MalfunctionDec 7, 2016Device Displays Incorrect Message; Battery Problem; Device Displays Incorrect Message; Battery Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED TO CHARGE ITS INTERNAL BATTERY AND A "SERVICE REQUIRED" ALARM CONDITION OCCURRED. THE DEVICE WAS NOT IN PATIENT USE. 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 ISSUES.
Patient problems: No Patient Involvement
MAUDE report 6151832 ↗MalfunctionAug 24, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
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, ERROR CODES RELATED TO THE CHARGING OF THE INTERNAL BATTERY WERE OBSERVED. THE DEVICE'S INTERNAL BATTERY AND POWER MANAGEMENT BOARD WERE REPLACED TO ADDRESS THE ISSUES.
Patient problems: No Patient Involvement
MAUDE report 5900065 ↗MalfunctionJul 27, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. 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 BLOWER MOTOR WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Patient Involvement
MAUDE report 5826023 ↗MalfunctionJun 15, 2016No Display/Image; No Display/Image
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S LCD SCREEN DID NOT DISPLAY ANY DATA. THE DEVICE WAS NOT IN PATIENT USE. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S LCD SCREEN WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Patient Involvement
MAUDE report 5726211 ↗MalfunctionMar 9, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
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 WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Patient Involvement
MAUDE report 5489287 ↗MalfunctionDec 9, 2015Failure to Charge
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED TO CHARGE ITS INTERNAL BATTERY. THE DEVICE WAS NOT IN PATIENT USE. THE VENTILATOR WAS SENT TO A THIRD PARTY SERVICE CENTER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Patient Involvement
MAUDE report 5277366 ↗MalfunctionOct 28, 2015Failure to Charge
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED TO CHARGE ITS INTERNAL BATTERY. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS OBSERVED 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 5185215 ↗MalfunctionOct 8, 2015Battery Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S INTERNAL BATTERY WAS DEPLETED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS OBSERVED 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 5134780 ↗MalfunctionOct 8, 2015Battery Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S INTERNAL BATTERY WAS DEPLETED. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS OBSERVED IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5134729 ↗
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, ClassifiedPhilips 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, ClassifiedPhilips Garbin Ventilator, Model Number 1058180B
- Z-1956-2021 · Jun 14, 2021 · Open, ClassifiedTrilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
- Z-1065-2016 · Jan 18, 2016 · TerminatedTrilogy 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 · TerminatedTrilogy 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 · TerminatedRespironics 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 · TerminatedTrilogy 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 · TerminatedTrilogy 100 Ventilator, Model/Catalog Number 1054260, U1054260 (Domestic). Philips Respironics, Monroeville, PA 15146. Provides continuous or intermittent ventilatory support for
Other VENTILATOR, CONTINUOUS, FACILITY USE devices
- Trilogy Trilogy100 Ventilator, United StatesRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE92 deaths8,161 reports
- Trilogy Evo Trilogy Evo, USARespironics, Inc. · Ventilator, continuous, facility use6 recalls50 deaths4,393 reports
- Trilogy 100 Trilogy 100 W/ Bluetooth, USARespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE65 deaths4,569 reports
- CARESCAPE R860Datex-Ohmeda Inc · VENTILATOR, CONTINUOUS, FACILITY USE1 recall1 death4,346 reports
- HAMILTON-C1 161001Hamilton Medical AG · Ventilator, Continuous, Facility Use2 recalls12 deaths1,849 reports
- Trilogy Trilogy O2 Ventilator JapanRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE7 deaths1,900 reports
- Trilogy Trilogy 202 Ventilator InternationalRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE11 deaths1,564 reports
- HAMILTON-C6 160021Hamilton Medical AG · Ventilator, Continuous, Facility Use5 recalls10 deaths1,175 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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