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Trilogy Trilogy100 Ventilator, InternationalRecalls & reported problems

Respironics, Inc. · Trilogy 100 Ventilator, International version · 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 100 ventilator has 2,498 adverse event reports, including 8 deaths and 6 injuries. Many reports describe operating problems, failures to charge, battery faults and incorrect messages on the screen, and many note no impact on the patient. Reports rose to 537 in the last 12 months from 114 in the 12 months before. 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
2,493
Deaths reported
8
Injuries reported
6
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2,493 adverse event reports that list this exact device (DI 00606959022744), received between Sep 30, 2015 and Sep 25, 2026 — classified as 8 deaths, 6 injuries, 2,477 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (341 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.

Reports received per month

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 3 reportsFeb 2024: 4 reportsMar 2024: 2 reportsApr 2024: 10 reportsMay 2024: 21 reportsJun 2024: 3 reportsJul 2024: 2 reportsAug 2024: 4 reportsSep 2024: 4 reportsOct 2024: 5 reportsNov 2024: 2 reportsDec 2024: 7 reportsJan 2025: 5 reportsFeb 2025: 3 reportsMar 2025: 24 reportsApr 2025: 7 reportsMay 2025: 12 reportsJun 2025: 7 reportsJul 2025: 12 reportsAug 2025: 16 reportsSep 2025: 15 reportsOct 2025: 4 reportsNov 2025: 7 reportsDec 2025: 6 reportsJan 2026: 6 reportsFeb 2026: 18 reportsMar 2026: 102 reportsApr 2026: 324 reportsMay 2026: 46 reportsJun 2026: 14 reportsJul 2026: 7 reportsAug 2026: 0 reportsSep 2026: 2 reportsOct 2026: 0 reports202420252026324
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device Operational Issue341
  • Failure to Charge312
  • Battery Problem275
  • Device Displays Incorrect Message236
  • Incorrect Or Inadequate Test Results219
  • Mechanical Problem172
  • Device Sensing Problem155
  • Degraded140

Patient problems

  • No Clinical Signs, Symptoms or Conditions944
  • No Consequences Or Impact To Patient899
  • No Patient Involvement649
  • No Known Impact Or Consequence To Patient35
  • Death3
  • Low Oxygen Saturation3
  • Respiratory Distress3
  • Insufficient Information2

Recent adverse event reports

The 25 most recent of 2,493 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 25, 2026Failure to Recalibrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50906002 ↗
  • MalfunctionSep 25, 2026Mechanical Problem; Failure to Recalibrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50905933 ↗
  • MalfunctionJul 1, 2026Battery Problem

    A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S INTERNAL BATTERY NEEDS TO BE REPLACED, AND THE SOFTWARE WAS UPGRADED TO ADDRESS THE ISSUE. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS NOT CONFIRMED ALONG WITH CONTAMINATION, AND THE DEVICE WAS CORRECTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25675650 ↗
  • MalfunctionJul 1, 2026Failure to Charge

    A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S INTERNAL BATTERY NEEDS TO BE REPLACED, AND THE SOFTWARE WAS UPGRADED TO ADDRESS THE ISSUE. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS NOT CONFIRMED ALONG WITH CONTAMINATION, AND THE DEVICE WAS CORRECTED. HANDLE IS CRACKED; RUBBER FEET ARE MISSING. RARE CASE IS DAMAGE, LCD GLASS SCRATCHED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25675649 ↗
  • MalfunctionJul 1, 2026Failure to Charge; Battery Problem

    A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S INTERNAL LI-ION BATTERY WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS NOT CONFIRMED ALONG WITH CONTAMINATION, AND THE DEVICE WAS CORRECTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25675642 ↗
  • MalfunctionJul 1, 2026Failure to Charge; Failure to Recalibrate; Battery Problem

    A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, "SERVICE REQUIRED" CODES WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG, AND THE DEVICE FAILED AT TEST STEP FOR LCD SCREEN DURING TESTING. THE DEVICE'S INTERNAL BATTERY NEED TO BE REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, CONTAMINATION WAS ALSO OBSERVED AND THE DEVICE WAS CORRECTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25675521 ↗
  • MalfunctionJul 1, 2026Failure to Charge; Battery Problem; Noise, Audible

    A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, "SERVICE REQUIRED" CODES WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. ADDITIONALLY, CONTAMINATION WAS ALSO OBSERVED AND THE DEVICE WAS CORRECTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25675520 ↗
  • MalfunctionJul 1, 2026Electrical /Electronic Property Problem; Mechanical Problem; Failure to Recalibrate

    A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A VENTILATOR INOPERATIVE CONDITION OCCURRED, AND THE DEVICE FAILED AT TEST STEP FOR CHECK LEAK: CONTROL FLOW SENSOR DURING TESTING. THE FOAM HAD BEEN VERIFIED AND WAS INSTALLED CORRECTLY. ADDITIONALLY, CONTAMINATION WAS ALSO OBSERVED AND THE DEVICE WAS CORRECTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25675519 ↗
  • MalfunctionJul 1, 2026Failure to Charge; Mechanical Problem; Battery Problem

    A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, "SERVICE REQUIRED" CODES AND ERROR CODES RELATED TO VENTILATOR INOPERATIVE CONDITION WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. ADDITIONALLY, THE DEVICE WAS SCRAPPED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25675518 ↗
  • MalfunctionJun 30, 2026Circuit Failure

    A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A "VENTILATOR INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG RELATED TO ERR_DSP_MOTOR_FAILURE. THE DEVICE'S SYSTEM BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. THE FOAM HAS BEEN INSTALLED CORRECTLY. ADDITIONALLY, DUST ON BLOWER BOX WAS ALSO OBSERVED AND THE DEVICE WAS CORRECTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25670330 ↗
  • MalfunctionJun 30, 2026Electrical /Electronic Property Problem

    A TRILOGY 100 VENTILATOR DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION, THE SERVICE TECHNICIAN OBSERVED CELL UNDERVOLTAGE ERROR CODE E210 (ERR_TDA_CELL_UNDER_VOLTAGE_INT_BATTERY_LOG _ONLY) IN THE ERROR LOG. THIS ERROR IS GENERATED FROM A BATTERY CELL UNDER-VOLTAGE INSIDE THE BATTERY PACK. NO DOCUMENTATION OF A REPLACED COMPONENT TO ADDRESS THE ISSUE. ADDITIONALLY, THE ACTIVE EXHALATION PORTING BLOCK WAS DAMAGED, THE POWER CORD CLAMP WAS MISSING, THE DISPLAY WAS DAMAGED, AND THE MAINTENANCE LABEL AND POLLEN AIR FILTER NEEDED TO BE REPLACED DUE TO PREVENTIVE MAINTENANCE. NO PARTS WILL BE REPLACED; THE DEVICE WILL BE SCRAPPED AS PER CUSTOMER REQUEST.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25669958 ↗
  • MalfunctionJun 29, 2026Failure to Charge; Battery Problem

    A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A SERVICE REQUIRED CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG RELATED TO ERR_PERM_FAIL_INT_LI_ION. THE FOAM HAS BEEN INSTALLED CORRECTLY. ADDITIONALLY, DUST ON BLOWER BOX WAS ALSO OBSERVED AND THE DEVICE WAS CORRECTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25659759 ↗
  • MalfunctionJun 29, 2026Failure to Charge; Battery Problem

    A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A SERVICE REQUIRED CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG RELATED TO ERR_PERM_FAIL_INT_LI_ION. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, CONTAMINATION ON BLOWER BOX WAS ALSO OBSERVED AND THE DEVICE WAS CORRECTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25659486 ↗
  • MalfunctionJun 29, 2026Failure to Charge; Battery Problem

    A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A SERVICE REQUIRED CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG RELATED TO ERR_PERM_FAIL_INT_LI_ION. THE DEVICE'S INTERNAL BATTERY NEEDS REPLACED TO ADDRESS THE ISSUE. THE FOAM HAS BEEN INSTALLED CORRECTLY. ADDITIONALLY, DUST ON BLOWER BOX WAS ALSO OBSERVED AND THE DEVICE WAS CORRECTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25659484 ↗
  • MalfunctionJun 29, 2026Failure to Charge; Battery Problem

    A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A SERVICE REQUIRED CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG RELATED TO ERR_PERM_FAIL_INT_LI_ION. THE DEVICE'S INTERNAL BATTERY NEEDS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, DUST ON BLOWER BOX WAS ALSO OBSERVED AND THE DEVICE WAS CORRECTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25659481 ↗
  • MalfunctionJun 26, 2026Circuit Failure; Electrical /Electronic Property Problem

    THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY 100 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. IT WAS REPORTED THERE WERE NO VISIBLE FOAM PARTICLES IN THE DEVICE. TECHNICAL FINDINGS ON DEVICE EVALUATION INDICATED THE MACHINE FLOW SENSOR AND THE SENSOR PRINTED CIRCUIT BOARD ASSEMBLY WERE DEFECTIVE. THE EVALUATION DETAILS INDICATE NO DEVICE ERROR CODES WERE REPORTED, AND THE ACTION TAKEN WAS "UNREPAIIRED". THE DEVICE OPERATING SOFTWARE WAS REPORTED TO HAVE BEEN UPGRADED. THE EVALUATION REPORTED THE DEVICE DID NOT PASS FINAL TESTING. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: IT WAS REPORTED THE INTERFACE PRINTED CIRCUIT BOARD ASSEMBLY WAS PHYSICALLY DAMAGED AND THE BLOWER WAS "NOISY". IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25635751 ↗
  • MalfunctionJun 18, 2026Failure to Charge; Battery Problem

    A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S INTERNAL BATTERY NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, KEYPAD IS OVERUSED., HANDLE O-RINGS REPLACEMENT REQUIRED, RUBBER FEET ARE MISSING, 10K PM REQUIRED, BOTTOM CASE IS DAMAGED, HANDLE REPLACEMENT REQUIRED, WARRANTY LABEL NEED TO BE CHANGED. THERE WAS DUST ON BLOWER BOX AND THE DEVICE WAS CORRECTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25553944 ↗
  • MalfunctionJun 18, 2026Failure to Charge; Battery Problem

    A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A SERVICE REQUIRED CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S INTERNAL BATTERY NEEDS REPLACED TO ADDRESS THE ISSUE. THE FOAM WAS INSTALLED CORRECTLY. ADDITIONALLY, DUST ON BLOWER BOX WAS ALSO OBSERVED AND THE DEVICE WAS CORRECTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25551644 ↗
  • MalfunctionJun 18, 2026Failure to Charge; Battery Problem

    A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A SERVICE REQUIRED CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S INTERNAL BATTERY NEEDS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, DUST ON BLOWER BOX WAS ALSO OBSERVED AND THE DEVICE WAS CORRECTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25551641 ↗
  • MalfunctionJun 18, 2026Failure to Charge; Battery Problem

    A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A SERVICE REQUIRED CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S INTERNAL BATTERY NEEDS REPLACED TO ADDRESS THE ISSUE. THE FOAM WAS INSTALLED CORRECTLY. ADDITIONALLY, DUST ON BLOWER BOX WAS ALSO OBSERVED AND THE DEVICE WAS CORRECTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25551640 ↗
  • MalfunctionJun 18, 2026Failure to Charge; Failure to Recalibrate; Battery Problem

    A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A SERVICE REQUIRED CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG, AND THE DEVICE FAILED A TEST STEP FOR LCD SCREEN TEST DURING TESTING. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE. THE FOAM WAS INSTALLED CORRECTLY. ADDITIONALLY, UNKNOWN CONTAMINATION WAS ALSO OBSERVED AND THE DEVICE WAS CORRECTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25551638 ↗
  • MalfunctionJun 12, 2026Failure to Charge; Battery Problem

    A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, "SERVICE REQUIRED" CODES WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S INTERNAL BATTERY NEED TO BE REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, THE DEVICE WAS CORRECTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25491767 ↗
  • MalfunctionJun 12, 2026Failure to Recalibrate

    A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED A TEST STEP FOR RED ALARM DURING TESTING. THE FOAM HAS BEEN VERIFIED AND WAS INSTALLED CORRECTLY ADDITIONALLY, HANDLE O-RINGS REPLACEMENT REQUIRED. RUBBER FEET ARE MISSING. HANDLE IS DAMAGED. NO PM REQUIRED. THERE WAS DUST ON BLOWER BOX. THE UNIT CAME FOR REMEDIATION ONLY AND WILL BE SEND BACK UNREPAIRED AFTER PM TEST IS PERFORMED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25487658 ↗
  • MalfunctionMay 27, 2026Mechanical Problem; Failure to Calibrate

    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 THE ACTIVE EXHALATION PURGE VALVE AND PROPORTIONAL VALVE TEST STEPS. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. THE CUSTOMER REFUSED THE REPAIR QUOTE AND REQUESTED THE DEVICE BE RETURNED UNREPAIRED. THE DEVICE WAS RETURNED UNREPAIRED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25299609 ↗
  • MalfunctionMay 27, 2026Failure to Calibrate; Device Sensing Problem

    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 THE POSITIVE FLOW CALIBRATION AND POSITIVE FLOW VERIFICATION TEST STEPS. CALIBRATION WAS ATTEMPTED BUT FAILED TO RESOLVE THE ISSUE. THE DEVICE'S FLOW SENSOR NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. THE CUSTOMER REFUSED THE REPAIR QUOTE AND REQUESTED THE DEVICE BE RETURNED UNREPAIRED. THE DEVICE WAS RETURNED UNREPAIRED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25299605 ↗

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

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