TRILOGY TRILOGY 202 VENTILATOR, U.S.A-RECERTRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00606959026254), received between Mar 9, 2016 and Oct 19, 2016 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Inoperable” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K093905); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTIVE 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, IT WAS OBSERVED THAT THE INTERNAL BATTERY'S CHARGE DEPLETED RAPIDLY. THE DEVICE'S POWER MANAGEMENT BOARD AND INTERNAL BATTERY WERE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 6040943 ↗
• MalfunctionJun 1, 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 5691147 ↗
• MalfunctionMar 23, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTIVE 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 SENSOR BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 5519543 ↗
• MalfunctionMar 16, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTIVE 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 POWER MANAGEMENT BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 5503776 ↗
• MalfunctionMar 15, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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 OXYGEN BLENDING MODULE BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 5501371 ↗
• MalfunctionMar 15, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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 POWER MANAGEMENT BOARD AND INTERNAL BATTERY WERE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 5501360 ↗
• MalfunctionMar 9, 2016Device Inoperable; Appropriate Device Problem Term/Code Not Available; Device Inoperable; 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 "VENTILATOR INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SYSTEM BOARD AND BLOWER MOTOR WERE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5489658 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093905. One submission often covers many models, so check the product and lot details in each record.

• 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