Trilogy Trilogy 100 w/Bluetooth, U.S.ARecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00606959023178), received between Apr 6, 2016 and Jan 9, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

7 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.

Recalls naming this device

1. Dec 7, 2022Open, Classified

   The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.

   Z-0882-2023 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A TRILOGY 100 VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE WITH THE ALLEGATION THE DEVICE FAILED INITIAL POWER UP. THERE WAS NO HARM OR INJURY REPORTED. DURING EVALUATION, THE DEVICE FAILED INITIAL POWER UP. THE ALLEGATION WAS CONFIRMED. NO REPAIRS WERE COMPLETED BECAUSE THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21111384 ↗
• MalfunctionMar 28, 2024Circuit Failure; Failure to Recalibrate; Circuit Failure; Failure to Recalibrate

  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 TEST STEP DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. CUSTOMER REQUESTS NO REPAIR TO DEVICE. UNIT WILL BE RETURNED TO CUSTOMER UNREPAIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18996965 ↗
• MalfunctionJan 19, 2024Mechanical Problem; Mechanical Problem

  A VENTILATOR 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 ACTIVE EXHALATION CONTROL MODULE HAD A TEST FAILURE. THE CUSTOMER REQUESTED THAT NO REPAIRS BE DONE TO THE UNIT. THE UNIT WILL BE RETURNED TO THE CUSTOMER UNREPAIRED. ADDITIONALLY, THE OVERLAY WAS SCRATCHED COSMETICALLY, AND THE FEET NEEDED TO BE REPLACED. THE INLET AIR PATH ASSEMBLY AND REMOVABLE AIR PATH FOAM WERE REPLACED PER REMEDIATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18544945 ↗
• MalfunctionOct 4, 2022No Display/Image; No Display/Image

  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'S LCD SCREEN WAS FOUND TO BE BLANK. THE DEVICE'S LCD SCREEN NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. THE DEVICE IS BEING RETURNED TO THE CUSTOMER UNREPAIRED PER THE CUSTOMER'S REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15535321 ↗
• MalfunctionAug 17, 2022Failure to Power Up; Failure to Power Up

  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 FAILURE OF THE DEVICE'S LCD SCREEN WAS OBSERVED. THE MANUFACTURER'S INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15240397 ↗
• MalfunctionJun 3, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES IN THE AIR PATH. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14597443 ↗
• MalfunctionNov 16, 2021Mechanical Problem; Power Problem; Mechanical Problem; Power Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS ALARMING FOR A HIGH PRIORITY ALARM CONDITION AND THE DEVICE WAS REBOOTING. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER. 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 12820801 ↗
• MalfunctionJan 30, 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 FAILURE OF THE DEVICE TO POWER ON WAS OBSERVED. THE DEVICE'S SYSTEM BOARD, POWER SUPPLY, POWER MANAGEMENT BOARD AND INTERFACE BOARD NEED TO BE REPLACED TO ADDRESS THE ISSUE. THE INTERFACE BOARD HAD EVIDENCE OF A THERMAL EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7227575 ↗
• MalfunctionAug 2, 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, 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 6759798 ↗
• MalfunctionJan 25, 2017No Display/Image; No Display/Image

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT A THIRD PARTY SERVICE CENTER, A FAILURE OF THE DEVICE'S LCD SCREEN WAS OBSERVED. THE DEVICE'S LCD SCREEN WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 6275993 ↗
• MalfunctionDec 7, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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 POWER MANAGEMENT BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6151332 ↗
• MalfunctionApr 6, 2016No Display/Image; No Display/Image

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S LCD SCREEN WAS BROKEN. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION. THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S LCD SCREEN WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 5551241 ↗

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-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