Trilogy Trilogy 100 Ventilator, ChinaRecalls & reported problems

Summary

The FDA's MAUDE database contains 447 adverse event reports that list this exact device (DI 00606959022171), received between Sep 23, 2015 and May 20, 2026 — classified as 1 death, 1 injury, 445 malfunctions.

The most frequently reported specific device problem is “Degraded” (242 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 447 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A "VENTILATOR IS NOT FUNCTIONING" AND DISPLAYING A RED SCREEN ON A TRILOGY 100 DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE DEVICE WAS REPLACED WITH ANOTHER ONE AT THE CUSTOMER SITE. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. PHILIPS IS CURRENTLY INVESTIGATING THIS COMPLAINT; HOWEVER, THE DEVICE EXAMINATION HAS NOT BEGUN BECAUSE THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. AS PART OF THE COMPLAINT HANDLING PROCESS, THE MANUFACTURER WILL ATTEMPT TO RETRIEVE THE DEVICE FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25228867 ↗
• MalfunctionMay 8, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECIEVED AN ALLEGATION THAT DURING A TRILOGY 100 VENTILATOR EQUIPMENT STARTUP, AN EMERGENCY ALARM WAS TRIGGERED INDICATING THE VENTILATOR WAS NOT FUNCTIONING AND DISPLAYING A RED SCREEN RENDERING IT UNABLE TO TREAT THE PATIENT. SUBSEQUENTLY, ANOTHER DEVICE WAS USED, NO HARM WAS CAUSED TO THE PATIENT. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW UP WILL BE FILED SHOULD MORE INFORMATION TO CONCLUDE THE INVESTIGATION BE DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25120126 ↗
• MalfunctionMay 7, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT DURING THE STARTUP OF THE TRILOGY 100 VENTILATOR DEVICE, A VENTILATOR INOPERATIVE ALARM (EMERGENCY ALARM) WAS TRIGGERED, INDICATING THE VENTILATOR WAS NOT FUNCTIONING. THIS RESULTED IN THE DISPLAY OF A RED SCREEN, AND THE DEVICE STOPPED OPERATING, MAKING IT UNABLE TO TREAT THE PATIENT. THERE ARE NO ALLEGATIONS OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25116811 ↗
• MalfunctionApr 3, 2026Degraded

  A TRILOGY 100 VENTILATOR DEVICE 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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM PARTICLES WERE OBSERVED. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS CONFIRMED, AND THE DEVICE WAS CORRECTED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24777033 ↗
• MalfunctionApr 2, 2026Degraded

  THE MANUFACTURER WAS CONTACTED 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 RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR SERVICE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, FOAM PARTICLES WERE OBSERVED. DEVICE HAS BEEN CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766410 ↗
• MalfunctionApr 2, 2026Degraded

  A TRILOGY 100 VENTILATOR DEVICE 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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM PARTICLES WERE OBSERVED. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS CONFIRMED, AND THE DEVICE WAS CORRECTED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24762885 ↗
• MalfunctionApr 2, 2026Degraded

  A TRILOGY 100 VENTILATOR DEVICE 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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM PARTICLES WERE OBSERVED. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS CONFIRMED, AND THE DEVICE WAS CORRECTED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24762884 ↗
• MalfunctionApr 2, 2026Degraded

  A TRILOGY 100 VENTILATOR DEVICE 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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM PARTICLES WERE OBSERVED. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS CONFIRMED, AND THE DEVICE WAS CORRECTED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24762779 ↗
• MalfunctionApr 2, 2026Degraded

  A TRILOGY 100 VENTILATOR DEVICE 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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM PARTICLES WERE OBSERVED. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS CONFIRMED, AND THE DEVICE WAS CORRECTED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24762777 ↗
• MalfunctionApr 1, 2026Degraded

  THE MANUFACTURER WAS CONTACTED 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 RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR SERVICE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, FOAM PARTICLES WERE OBSERVED. DEVICE HAS BEEN CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756546 ↗
• MalfunctionApr 1, 2026Degraded

  THE MANUFACTURER WAS CONTACTED 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 RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR SERVICE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, FOAM PARTICLES WERE OBSERVED. DEVICE HAS BEEN CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756545 ↗
• MalfunctionApr 1, 2026Degraded

  THE MANUFACTURER WAS CONTACTED 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 RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR SERVICE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, FOAM PARTICLES WERE OBSERVED. DEVICE HAS BEEN CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756339 ↗
• MalfunctionApr 1, 2026Degraded

  THE MANUFACTURER WAS CONTACTED 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 RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR SERVICE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, FOAM PARTICLES WERE OBSERVED. DEVICE HAS BEEN CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756283 ↗
• MalfunctionApr 1, 2026Degraded

  THE MANUFACTURER WAS CONTACTED 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 RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR SERVICE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, FOAM PARTICLES WERE OBSERVED. DEVICE HAS BEEN CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756245 ↗
• MalfunctionApr 1, 2026Degraded

  THE MANUFACTURER WAS CONTACTED 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 RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR SERVICE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, FOAM PARTICLES WERE OBSERVED. DEVICE HAS BEEN CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756240 ↗
• MalfunctionApr 1, 2026Degraded

  THE MANUFACTURER WAS CONTACTED 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 RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR SERVICE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, FOAM PARTICLES WERE OBSERVED. DEVICE HAS BEEN CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756205 ↗
• MalfunctionApr 1, 2026Degraded

  THE MANUFACTURER WAS CONTACTED 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 RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR SERVICE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, FOAM PARTICLES WERE OBSERVED. DEVICE HAS BEEN CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756202 ↗
• MalfunctionApr 1, 2026Degraded

  THE MANUFACTURER WAS CONTACTED 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 RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR SERVICE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, FOAM PARTICLES WERE OBSERVED. DEVICE HAS BEEN CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756035 ↗
• MalfunctionApr 1, 2026Degraded

  THE MANUFACTURER WAS CONTACTED 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 RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR SERVICE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, FOAM PARTICLES WERE OBSERVED. DEVICE HAS BEEN CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756032 ↗
• MalfunctionApr 1, 2026Degraded

  THE MANUFACTURER WAS CONTACTED 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 RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR SERVICE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, FOAM PARTICLES WERE OBSERVED. DEVICE HAS BEEN CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24752536 ↗
• MalfunctionMar 31, 2026Degraded

  A TRILOGY 100 VENTILATOR DEVICE 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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM PARTICLES WERE OBSERVED. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS CONFIRMED, AND THE DEVICE WAS CORRECTED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747858 ↗
• MalfunctionMar 31, 2026Degraded

  A TRILOGY 100 VENTILATOR DEVICE 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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM PARTICLES WERE OBSERVED. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS CONFIRMED, AND THE DEVICE WAS CORRECTED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747857 ↗
• MalfunctionMar 31, 2026Degraded

  A TRILOGY 100 VENTILATOR DEVICE 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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM PARTICLES WERE OBSERVED. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS CONFIRMED, AND THE DEVICE WAS CORRECTED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747856 ↗
• MalfunctionMar 31, 2026Degraded

  A TRILOGY 100 VENTILATOR DEVICE 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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM PARTICLES WERE OBSERVED. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS CONFIRMED, AND THE DEVICE WAS CORRECTED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747625 ↗
• MalfunctionMar 31, 2026Degraded

  A TRILOGY 100 VENTILATOR DEVICE 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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM PARTICLES WERE OBSERVED. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS CONFIRMED, AND THE DEVICE WAS CORRECTED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747624 ↗

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