Skip to content

Trilogy 00 (REF R1054097)Recalls & reported problems

Respironics, Inc. · Trilogy100 Ventilator, Rental, German version · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00606959026285), received between Apr 16, 2019 and Sep 24, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (1 report).

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.

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: 0 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: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Battery Problem1
  • Circuit Failure1
  • Electrical /Electronic Property Problem1
  • Mechanical Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 24, 2026Battery Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50888935 ↗
  • MalfunctionMay 28, 2026Circuit Failure; Electrical /Electronic Property Problem

    A TRILOGY 100 VENTILATOR, GERMANY- RENTAL DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO ALLEGATION OF PATIENT HARM. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION, THE SERVICE TECHNICIAN CONFIRMED ERROR CODE 189 (ERR_LOSS_OF_VBATT_LI_POWER) FROM THE DEVICE ERROR CODE LOG, AND THE POWER MANAGEMENT PRINTED CIRCUIT ASSEMBLY (PCA) NEEDS TO BE REPLACED TO ADDRESS THIS ERROR. ADDITIONALLY, THE SERVICE TECHNICIAN NOTED THAT THE POLLEN AIR FILTER AND MAINTENANCE LABEL NEED TO BE REPLACED DUE TO PREVENTATIVE MAINTENANCE. AFTER THE EVALUATION WAS COMPLETE, THE DEVICE WAS SCRAPPED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25317010 ↗
  • MalfunctionApr 16, 2019Mechanical Problem; Mechanical Problem

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO THE ACTIVE EXHALATION CONTROL MODULE WAS OBSERVED. 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 ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8519334 ↗

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

Other VENTILATOR, CONTINUOUS, FACILITY USE devices

All VENTILATOR, CONTINUOUS, FACILITY USE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.