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TRILOGY 100 RTO Trilogy 100 Ventilator, U.S.ARecalls & reported problems

Respironics, Inc. · RTO Trilogy 100 Ventilator, U.S.A · Class 2

All models of Philips Trilogy Ventilator (90) · Trilogy 100 (8)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
10
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00606959033900), received between Dec 22, 2016 and Aug 14, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (2 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Battery Problem2
  • Device Operational Issue2
  • Failure to Charge2
  • No Display/Image2
  • Aborted Charge1
  • Device Displays Incorrect Message1
  • Device Inoperable1
  • Premature Discharge of Battery1

Patient problems

  • No Patient Involvement5
  • No Consequences Or Impact To Patient3
  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 14, 2024Battery Problem; Battery Problem

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT A DEVICE DID NOT MEET ACCEPTANCE CRITERIA OF EVALUATION PROCESS DUE TO COSMETIC ISSUES AND CRITICAL ERRORS IN THE ERROR LOG. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, AN ERROR CODE RELATED TO THE CHARGING OF THE INTERNAL BATTERY WAS CONFIRMED. THE DEVICE WAS SCRAPPED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19981160 ↗
  • MalfunctionSep 22, 2020Failure 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 WAS REPLACED TO ADDRESS THE ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10567319 ↗
  • MalfunctionNov 8, 2017No Display/Image; No Display/Image

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S LCD SCREEN WAS DAMAGED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE VENTILATOR'S LCD SCREEN WAS FOUND TO BE BLANK. THE DEVICE'S LCD SCREEN WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE HAD EVIDENCE OF PHYSICAL DAMAGE.

    Patient problems: No Patient Involvement

    MAUDE report 7008924 ↗
  • MalfunctionSep 6, 2017Premature Discharge of Battery; Premature Discharge of Battery

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S INTERNAL BATTERY FAILED TO HOLD IT 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 6844798 ↗
  • MalfunctionJul 12, 2017Failure to Charge; Failure to Charge

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED TO CHARGE ITS INTERNAL BATTERY. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, "SERVICE REQUIRED" CODES RELATED TO THE CHARGING OF THE INTERNAL BATTERY WAS OBSERVED. THE DEVICE'S INTERNAL BATTERY AND POWER MANAGEMENT BOARD NEED TO BE REPLACED TO ADDRESS THE ISSUES.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6705921 ↗
  • MalfunctionJun 21, 2017Device 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, "SERVICE REQUIRED" CODES WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUES.

    Patient problems: No Patient Involvement

    MAUDE report 6656465 ↗
  • MalfunctionMay 10, 2017No Display/Image; No Display/Image

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S LCD SCREEN WAS DAMAGED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE WAS EVALUATED AT THE MANUFACTURER'S SERVICE CENTER 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 6556665 ↗
  • MalfunctionMar 29, 2017Aborted Charge; Aborted Charge

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED TO CHARGE ITS INTERNAL BATTERY. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE BATTERY CHARGING LIMIT WAS FOUND TO BE SET TO 65%. THE DEVICE'S BATTERY CHARGE LIMIT WAS RESET TO 100% TO CORRECT THE ISSUE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6442275 ↗
  • MalfunctionMar 1, 2017Device 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, 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 6367887 ↗
  • MalfunctionDec 22, 2016Device Inoperable; Device Displays Incorrect Message; Device Inoperable; Device Displays Incorrect Message

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE 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 SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.

    Patient problems: No Patient Involvement

    MAUDE report 6201323 ↗

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

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Sources and updates

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