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