Skip to content

Trilogy Trilogy200 Ventilator, JapanRecalls & reported problems

Respironics, Inc. · Trilogy 200 Ventilator, Japan · Class 2

All models of Philips Trilogy Ventilator (90) · Trilogy (46)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Respironics Trilogy 200 ventilator delivers breathing support. The 84 reports mostly mention the screen going blank or failing to show readings, along with recalibration failures and internal circuit or mechanical problems, and list no deaths and no injuries. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
84
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 00606959025370), received between Jan 6, 2016 and Oct 2, 2024 — classified as 84 malfunctions.

The most frequently reported specific device problem is “Failure to Recalibrate” (33 reports).

5 other recalls cover devices cleared under the same FDA submission (K093416); 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 reportsJan 2024: 2 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 8 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520268
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Recalibrate33
  • No Display/Image25
  • Mechanical Problem13
  • Circuit Failure6
  • Battery Problem2
  • Electrical /Electronic Property Problem2
  • Failure to Power Up2
  • Tidal Volume Fluctuations2

Patient problems

  • No Clinical Signs, Symptoms or Conditions83
  • No Patient Involvement1

Recent adverse event reports

The 25 most recent of 84 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 2, 2024No Display/Image; No Display/Image

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S LCD SCREEN WAS NOT DISPLAYING. THE CALL STATED THAT THE AIRFLOW WAS STILL BEING DELIVERED. THE SALES REPRESENTATIVE ARRIVED AT THE PATIENT'S HOME AND CONFIRMED THAT THE ISSUE HAD BEEN RESOLVED AND THE SCREEN WAS DISPLAYING. THE SALES REPRESENTATIVE CHECKED THE ALARM LOG AND EVENT LOG BUT WAS UNABLE TO FIND ANY SUCH ERRORS. THE PATIENT'S FAMILY STATED THAT EVEN WHEN THEY INTENTIONALLY GENERATED AN ALARM, ONLY THE SOUND SILENCE BUTTON LIGHTED IN RED, AND THE SCREEN REMAINED DARK. THE SALES REPRESENTATIVE REPLACED THE DEVICE TO AN ALTERNATIVE ONE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE COMPLAINT WAS UNABLE TO BE CONFIRMED BY OPERATIONAL CHECKING. IT WAS CONFIRMED THAT NO ERROR INDICATING A DEVICE FAILURE HAD BEEN RECORDED IN THE ERROR LOG. IT WAS DETERMINED THAT THE ISSUE WAS CAUSED BY A FAILURE TO THE LCD SCREEN. THE REPAIR WAS CANCELLED, AND THE UNIT WILL BE SCRAPPED DUE TO THE LEASE BEING UP.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20354515 ↗
  • MalfunctionJun 17, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

    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 ISSUE WAS CAUSED BY A FAILURE IN LCD. THE DEVICE'S LCD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19547582 ↗
  • MalfunctionJun 11, 2024Mechanical Problem; Mechanical Problem

    A TRILOGY 200 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, THE DEVICE FAILED A TEST STEP DURING TESTING. THE DEVICE'S ( AECM) ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE. IN ADDITION, THE FOLLOWING PARTS WERE REPLACED TO PREVENT FAILURE: EXHAUST FAN ASSEMBLY, POLLEN AND 43-MICRON FILTER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19513011 ↗
  • MalfunctionJun 11, 2024Mechanical Problem; Mechanical Problem

    A TRILOGY 200 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, THE DEVICE FAILED A TEST STEP DURING TESTING. THE DEVICE'S ( AECM) ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE. IN ADDITION, THE FOLLOWING PARTS WERE REPLACED TO PREVENT FAILURE: EXHAUST FAN ASSEMBLY, POLLEN AND 43-MICRON FILTER, MOTOR BLOWER ASSEMBLY, STIRRING FAN FOAM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19512750 ↗
  • MalfunctionJun 11, 2024No Display/Image; No Display/Image

    A TRILOGY 200 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, THE COMPLAINT OF THE WHOLE SCREEN TURNS BLACK, AND THE DISPLAYED CONTENTS ARE NOT ABLE TO BE VIEWED WAS CONFIRMED. THE ISSUE WAS CAUSED BY AND LCD FAILURE. THE DEVICE'S LCD WAS REPLACED TO ADDRESS THE ISSUE. IN ADDITION, THE FOLLOWING PARTS WERE REPLACED TO PREVENT FAILURE: EXHAUST FAN ASSEMBLY, POLLEN AND 43-MICRON FILTER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19508787 ↗
  • MalfunctionJun 10, 2024Circuit Failure; Failure to Recalibrate; Circuit Failure; Failure to Recalibrate

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. 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 SENSOR BOARD WAS REPLACED TO ADDRESS THE ISSUE. IN ADDITION OF THE ABOVE EVALUATION, THE TECHNICIAN PERFORMED REPAIR TEST, ALARM TEST, BATTERY TEST, RUN IN TESTS AND CLEANING THEN CONFIRMED THE UNIT OPERATED PROPERLY AND SOFTWARE VERSION WAS CHECKED, WHICH WAS NOT RELATED TO THE MALFUNCTION/ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19505258 ↗
  • MalfunctionJun 10, 2024Failure to Charge; Circuit Failure; Failure to Charge; Circuit Failure

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE'S CHARGE FAILURE OF THE BATTERY WAS OBSERVED. THE DEVICE'S POWER MANAGEMENT BOARD WAS REPLACED TO ADDRESS THE ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19500184 ↗
  • MalfunctionJun 10, 2024Failure to Recalibrate; Failure to Recalibrate

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. 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 WAS REPLACED TO ADDRESS THE ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19498263 ↗
  • MalfunctionJun 7, 2024No Display/Image; No Display/Image

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR PREVENTIVE MAINTENANCE. DURING THE EVALUATION OF THE DEVICE BY THE MANUFACTURER THE LCD SCREEN WAS BLACK AND UNABLE TO BE VIEWED. THE DEVICE'S LCD SCREEN WAS REPLACED TO ADDRESS THE ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19486757 ↗
  • MalfunctionMay 27, 2024Mechanical Problem; Failure to Recalibrate; Mechanical Problem; Failure to Recalibrate

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. 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 WAS REPLACED TO ADDRESS THE ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19400628 ↗
  • MalfunctionMar 8, 2024No Display/Image; No Display/Image

    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, IT WAS CONFIRMED WHOLE SCREEN TURNS COMPLETELY BLACK AND THE DISPLAYED CONTENTS ARE NOT ABLE TO BE VIEWED. THE DEVICE¿S LCD DISPLAY WAS REPLACED TO ADDRESS THE ISSUE.  IN ADDITION OF THE ABOVE EVALUATION, THE TECHNICIAN PERFORMED REPAIR TEST, ALARM CHECK, BATTERY CHECK, RUN IN TESTS AND CLEANING THEN CONFIRMED THE UNIT OPERATED PROPERLY AND SOFTWARE VERSION WAS CHECKED, WHICH WAS NOT RELATED TO THE MALFUNCTION/ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18869390 ↗
  • MalfunctionJan 24, 2024Electrical /Electronic Property Problem; Mechanical Problem; Electrical /Electronic Property Problem; Mechanical Problem

    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 CODE INDICATING CIRCUIT DISCONNECT ALARM HAD OCCURRED FREQUENTLY WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. SINCE IT WAS CONSIDERED THAT A TEMPORAL FAILURE HAD BEEN OCCURRING IN THE SENSOR, SENSOR PCA WAS REPLACED TO PREVENT RECURRENCE. ADDITIONALLY, THE ITEM FOR TESTING THE EXHALATION VALVE OF FUNCTIONAL TEST CONFIRMED THAT THE OPEN/CLOSE MOVEMENT OF THE VALVE WAS SLOW. THEREFORE, ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18571199 ↗
  • MalfunctionJan 10, 2024No Display/Image; No Display/Image

    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, IT WAS CONFIRMED WHOLE SCREEN TURNS COMPLETELY BLACK AND THE DISPLAYED CONTENTS ARE NOT ABLE TO BE VIEWED. THE DEVICE¿S LCD DISPLAY WAS REPLACED TO ADDRESS THE ISSUE. IN ADDITION OF THE TECHNICIAN PERFORMED REPAIR TEST, ALARM CHECK, BATTERY CHECK, RUN IN TESTS AND CLEANING THEN CONFIRMED THE UNIT OPERATED PROPERLY AND SOFTWARE VERSION WAS CHECKED, WHICH WAS NOT RELATED TO THE MALFUNCTION/ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18485722 ↗
  • MalfunctionDec 7, 2023Mechanical Problem; Mechanical Problem

    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 "CHECK CIRCUIT" ALARM OCCURRED. IT WAS DETERMINED THAT THE CAUSE WAS OPERATIONAL FAILURE OF ACTIVE EXHALATION CONTROL MODULE. THE ACTIVE EXHALATION CONTROL MODULE WAS REPLACED THEN THE ISSUE WAS RESOLVED. THE DEVICE PASSED FINAL TESTING AND THE SOFTWARE WAS CONFIRMED TO BE VERSION IS 14.2.05.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18283394 ↗
  • MalfunctionJul 24, 2023Battery Problem; Battery Problem

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S BATTERY FAILED TO CHARGE. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS NOT DUPLICATED. THE DEVICE OPERATED AND ALARMED AS DESIGNED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17379529 ↗
  • MalfunctionMay 19, 2023No 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 THE MANUFACTURER'S SERVICE CENTER, IT WAS OBSERVED THAT THE DEVICE'S LCD IS BLACK AND THE DISPLAY WAS NOT VIEWABLE. THE DEVICE¿S LCD DISPLAY NEEDS TO BE REPLACED TO ADDRESS THE ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16962813 ↗
  • MalfunctionApr 25, 2023Mechanical Problem; Mechanical Problem

    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, THE DEVICE FAILED A TEST STEP DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE. IN ADDITION OF THE ABOVE EVALUATION, THE DEVICE'S FOLLOWING PARTS WERE REPLACED AS REGULATED BY MAINTENANCE PROCEDURE TO PREVENT FAILURE: POLLEN FILTER, EXHAUST FAN ASSEMBLY, 43-MICRON FILTER. THE TECHNICIAN PERFORMED REPAIR TEST, ALARM CHECK, BATTERY CHECK, RUN IN TESTS, CLEANING THEN CONFIRMED THE UNIT OPERATED PROPERLY. THE DEVICE'S SOFTWARE VERSION WAS CHECKED. THE DEVICE'S THE AIR PATH FOAM AND THE INLET AIR PATH ASSEMBLY WILL BE REPLACED WHEN REPLACEMENT AIR PATH FOAMS AND INLET AIR PATH ASSEMBLIES ARRIVE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16810373 ↗
  • MalfunctionMar 6, 2023Failure to Recalibrate; Failure to Recalibrate

    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, THE DEVICE FAILED A TEST STEP DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16484298 ↗
  • MalfunctionDec 19, 2022Mechanical Problem; Mechanical Problem

    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, THE DEVICE FAILED A TEST STEP DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16009188 ↗
  • MalfunctionDec 7, 2022Failure to Recalibrate; Failure to Recalibrate

    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, THE DEVICE FAILED A TEST STEP DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15934114 ↗
  • MalfunctionDec 7, 2022Failure to Calibrate; Failure to Calibrate

    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, THE DEVICE FAILED A TEST STEP DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15932948 ↗
  • MalfunctionNov 18, 2022Circuit Failure; Circuit Failure

    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 SENSOR BOARD WAS REPLACED TO ADDRESS THE ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15826961 ↗
  • MalfunctionNov 18, 2022No Display/Image; No Display/Image

    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 FAULT OF THE DEVICE'S LCD SCREEN WAS OBSERVED. THE DEVICE'S LCD DISPLAY WAS REPLACED TO ADDRESS THE ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15825659 ↗
  • MalfunctionNov 7, 2022No Display/Image; No Display/Image

    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, THE LCD SCREEN WAS OBSERVED BLACK AND UNABLE TO BE VIEWED. THE DEVICE'S LCD DISPLAY WAS REPLACED TO ADDRESS THE ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15743875 ↗
  • MalfunctionNov 3, 2022Failure to Recalibrate; Failure to Recalibrate

    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, THE DEVICE FAILED A TEST STEP DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE BOARD WAS REPLACED TO ADDRESS THE ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15722297 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093416. One submission often covers many models, so check the product and lot details in each record.

  • Z-0883-2023 · Dec 7, 2022 · Open, Classified
    Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, 1032800, R1032804TP, R1032804B, R1032804TPV, 1032804B
  • 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

Other Oximeter devices

All Oximeter devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page