Trilogy Trilogy100 Ventilator, Latin AmericaRecalls & reported problems

Summary

The FDA's MAUDE database contains 154 adverse event reports that list this exact device (DI 00606959022836), received between Sep 23, 2015 and Sep 30, 2026 — classified as 154 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (37 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 154 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Power Up

  A device was returned to a service center in reference to the voluntary Field Safety Notice / recall notification related to the sound abatement foam in certain CPAP, BiPAP, and mechanical ventilator devices. There was no harm or injury reported.During the evaluation of the device at the third-party service center, the device was visually inspected and found no evidence of foam degradation. However, it was reported that the device failed to power on for evaluation and testing. It was reported the device was scrapped without further investigation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949244 ↗
• MalfunctionSep 28, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923084 ↗
• MalfunctionSep 28, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923080 ↗
• MalfunctionSep 28, 2026Failure to Power Up

  The manufacturer received information that a Trilogy 100 Ventilator device was returned to a third-party service center. There was no patient involvement and no allegation of serious or permanent harm or injury. During the evaluation, the service technician observed that the device had no power/did not turn on.Additionally, no visible foam particles were found. The evaluation did not identify any specific component malfunction that would need to be replaced to resolve the no-power issue. The device did not read the data; therefore, no access to information. The device was scrapped.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922504 ↗
• MalfunctionSep 28, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921553 ↗
• MalfunctionSep 28, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921548 ↗
• MalfunctionSep 28, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921547 ↗
• MalfunctionSep 28, 2026Failure to Power Up

  A Trilogy 100 was returned to the manufacturer's service center for evaluation. There was no harm or injury reported. There was no evidence the device was in patient use. During the evaluation the device failed to power on. There was no documentation of any components replaced to address this issue.There was no evidence of foam degradation. No repairs were performed. The device was scrapped.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917561 ↗
• MalfunctionSep 28, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916349 ↗
• MalfunctionSep 28, 2026Failure to Power Up

  The manufacturer received information that a Trilogy100 Ventilator, Latin America device did not turn on. There was no patient involvement, and no harm or injury reported.There was no evidence of foam degradation during the device evaluation. The device evaluation does not identify any specific component malfunction that would need to be replaced to resolve the no power issue. The device was scrapped.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916054 ↗
• MalfunctionSep 28, 2026Failure to Power Up

  The manufacturer received information that a Trilogy 100 ventilator was returned to a third-party service center for evaluation. There was no patient involvement, and no harm or injury reported. The device was returned in reference to the voluntary Field Safety Notice / recall notification related to the sound abatement foam in certain CPAP, BiPAP, and mechanical ventilator devices.On device evaluation, it was reported the device did not power on for a full evaluation and no device information was accessible. There was no evidence of foam degradation in the device. The device was scrapped without further evaluation or repair.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915470 ↗
• MalfunctionSep 28, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914549 ↗
• MalfunctionSep 28, 2026Failure to Power Up

  The manufacturer received a report that a Trilogy 100 ventilator was returned for evaluation. No patient injury or serious harm was reported.The device was evaluated at a manufacturer service center. A visual inspection was performed, and no evidence of foam particles or foam degradation was observed. The device failed to power on during assessment. In addition, the data was unable to be read as there was no access to the information.No documentation regarding component replacement was available. No repair activities were performed. The device was scrapped.A final report is being submitted. If any additional information is received, a supplemental report will be filed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913881 ↗
• MalfunctionSep 24, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890327 ↗
• MalfunctionSep 24, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890324 ↗
• MalfunctionSep 24, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890323 ↗
• MalfunctionSep 24, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890321 ↗
• MalfunctionSep 24, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890318 ↗
• MalfunctionSep 24, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890317 ↗
• MalfunctionSep 24, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890316 ↗
• MalfunctionMar 18, 2026Electrical /Electronic Property Problem; Mechanical Problem

  THE TRILOGY100 VENTILATOR, LATIN AMERICA DEVICE WAS RETURNED FOR EVALUATION AT A THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER NO VISIBLE FOAM PARTICLES WERE REPORTED, HOWEVER, A VENTILATOR INOPERATIVE ERROR WAS DISCOVERED IN THE DEVICE'S EVENT LOG. THE DEVICE'S MOTOR BLOWER ASSEMBLY WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, THE DEVICE'S OPERATING SOFTWARE UPGRADED. THE DEVICE PASSED FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24632505 ↗
• MalfunctionMar 10, 2026Degraded

  A TRILOGY 100 DEVICE WAS EVALUATED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO EVIDENCE THE DEVICE WAS IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE, AT A THIRD-PARTY SERVICE CENTER THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. THERE WAS NO MALFUNCTION OF THE DEVICE WAS NOTED. THERE WERE NO ACTIONABLE ERRORS OBSERVED. NO COMPONENTS WERE REPLACED. THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560314 ↗
• MalfunctionMar 10, 2026Failure to Power Up

  THE MANUFACTURER RECEIVED INFORMATION A TRILOGY 100 VENTILATOR WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS EVALUATED AND CONFIRMED NO FOAM PARTICLES VISUALIZED INSIDE THE DEVICE. ON TESTING, THE VENTILATOR FAILED TO POWER ON; THE DEVICE DID NOT READ THE DATA. IT WAS REPORTED THAT THE DEVICE WAS SCRAPPED AS NO FURTHER EVALUATION POSSIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557972 ↗
• MalfunctionMar 10, 2026Degraded

  THE TRILOGY100 VENTILATOR WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR INVESTIGATION. DURING EVALUATION, EVIDENCE OF (FOAM DEGRADATION INSIDE THE ASSEMBLY, DETERIORATED FOAM) WAS PRESENT. THERE WERE NO REPAIRS PERFORMED AND THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24556769 ↗
• MalfunctionMar 9, 2026Degraded

  A TRILOGY 100 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THERE WERE NO ALLEGATIONS OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS NOT DOCUMENTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND EVIDENCE OF VISIBLE FOAM PARTICLES. THE DEVICE WAS SCRAPPED. A FINAL REPORT IS BEING SUBMITTED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24546137 ↗

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