Trilogy 00 (REF U1054260)Recalls & reported problems

Summary

The FDA's MAUDE database contains 135 adverse event reports that list this exact device (DI 00606959026315), received between Nov 18, 2015 and Aug 27, 2026 — classified as 1 death, 3 injuries, 131 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (30 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 135 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Electrical /Electronic Property Problem; Battery Problem

  A Trilogy 100 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. During the evaluation of the device at a third-party service center, the device was visually inspected and found no evidence of foam degradation. However, error codes indicating an Internal Li-Ion Battery Permanent Failure and LOSS_OF_COMM_INT_LI_ION occurred was observed in the device event log. No repairs were performed and the device will be scrapped.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50488368 ↗
• MalfunctionAug 12, 2026Thermal Decomposition of Device; Electrical /Electronic Property Problem; Communication or Transmission Problem; Power Problem

  The Trilogy 100 Ventilator was returned to the third-party service center for remediation. The device was not in use on a patient at the time of the occurrence. During the evaluation the device failed a test step for communication during testing. Upon further investigation of the device the service center states the device does not power on and has a burning smell. The device was disassembled and the Power Board was found to be burned. In conclusion, the System Board with Daughter and Power Management Board were replaced to address the issues. The service center confirmed both power-on and communication were successfully validated after the repairs. Additionally, during the service of the device, the device failed testing for SD Locked Card Inserted: SD Detected unrelated to the reportable malfunction. The SD card socket does not retain the memory card, causing the reported failure. The System Board with Daughter was installed to validate the device, and it completed all tests successfully. Components were replaced as part of maintenance of the device or due to physical/cosmetic damage. The device was retested and passed all test. This device been serviced, inspected, tested, met a

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50218991 ↗
• MalfunctionMay 29, 2026Circuit Failure; Failure to Calibrate

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY 100 VENTILATOR WAS RETURNED FOR SERVICE. NO PATIENT HARM OR INJURY WAS REPORTED. DURING EVALUATION AT THE THIRD-PARTY SERVICE CENTER, THE POWER CORD CLAMP AND RUBBER FEET WERE FOUND TO BE MISSING. IN ADDITION, THE EXHALATION PORT BLOCK AND BASE ENCLOSURE KIT WERE OBSERVED TO BE DAMAGED, AND THE REAR ASSEMBLY WAS NOTED TO BE CRACKED. THE LCD SCREEN WAS ALSO FOUND TO BE DAMAGED AND REQUIRED REPLACEMENT. THERE WAS NO ALLEGATION THAT THE DISPLAY WAS UNREADABLE OR UNUSABLE PRIOR TO REPAIR. DURING FUNCTIONAL TESTING, THE DEVICE FAILED THE CHECK FOR LEAK: CONTROL FLOW SENSOR TEST. INVESTIGATION DETERMINED THAT THE PRINTED CIRCUIT ASSEMBLY (PCA) WAS DAMAGED AND REQUIRED REPLACEMENT. FOLLOWING THE REPAIR, THE DEVICE PASSED ALL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333436 ↗
• MalfunctionMay 21, 2026Mechanical Problem; Failure to Calibrate

  THE TRILOGY 100 WAS RETURNED TO THE THIRD PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD PARTY SERVICE CENTER, THE DEVICE FAILED THE ACTIVE EXHALATION PROPORTIONAL VALVE TEST STEP DURING TESTING. THE DEVICE HAS BEEN RETURNED AND EVALUATED BY A THIRD PARTY SERVICE CENTER. THE ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE TEST STEP FAILURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241802 ↗
• MalfunctionMay 12, 2026Failure to Power Up

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY 100 VENTILATOR WAS RETURNED FOR SERVICE. NO PATIENT INJURY OR SERIOUS HARM WAS REPORTED. DURING EVALUATION AT A THIRD-PARTY SERVICE CENTER, THE DEVICE LOG FILES COULD NOT BE RETRIEVED, AND THE DEVICE WOULD NOT POWER ON. A VISUAL INSPECTION WAS PERFORMED, AND NO EVIDENCE OF FOAM PARTICLES OR FOAM DEGRADATION WAS OBSERVED. THE DEVICE ENCLOSURE WAS REPORTED TO BE CRACKED AND THE FILTER WAS MISSING. NO DOCUMENTATION WAS AVAILABLE REGARDING COMPONENT REPLACEMENT, AND 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 25150501 ↗
• MalfunctionApr 17, 2026Circuit Failure; Computer Software Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT THE SIGNIFICANT EVENT LOG AND HW POWER FAIL TEST STEPS HAD FAILED ON A TRILOGY 100 DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY 100 DEVICE WAS BEING EVALUATED AT A THIRD-PARTY SERVICE CENTER WHEN THE REPORTED ISSUE OCCURRED ON THE DEVICE. DURING THE EVALUATION IT WAS NOTED THAT THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) AND SOFTWARE HAD CAUSED THE SIGNIFICANT EVENT LOG AND HW POWER FAIL TEST STEP TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S SYSTEM PCA WAS REPLACED, AND SOFTWARE WAS REINSTALLED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE RUBBER FEET AND HANDLE O-RING WERE REPLACED FOR MISSING ON THE DEVICE. THIS WAS UNRELATED TO THE REPORTABLE ISSUE. THE EXHALATION PORT BLOCK AND REAR CASE ENCLOSURE WERE REPLACED FOR PHYSICAL DAMAGE UNRELATED TO THE REPORTABLE MALFUNCTION/ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24917964 ↗
• MalfunctionJan 1, 2026Circuit Failure; Failure to Calibrate

  A TRILOGY 100 VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING EVALUATION OF THE DEVICE AT THE MANUFACTURER, THE DEVICE FAILED A TEST STEP RELATING TO THE PRIMARY AND SECONDARY AUDIBLE ALARMS. THE SERVICE TECHNICIAN STATES THAT DURING THE EVALUATION, THE UNIT POWERED ON AND THE SPEAKERS NOTICEABLY DID NOT WORK, CONFIRMING THE TEST FAILURE. THE SERVICE TECHNICIAN TRIED REPLACING THE SPEAKER KIT AND REASSEMBLED THE DEVICE AND THE SPEAKERS STILL DID NOT WORK. IT WAS DETERMINED THAT THE FRONT PANEL PRINTED CIRCUIT ASSEMBLY (PCA) BOARD WAS FAULTY AND NEEDS TO BE REPLACED TO RESOLVE THE ISSUE. ADDITIONALLY, THE BASE ENCLOSURE IS CRACKED AND NEEDS TO BE REPLACED. THE FRONT CASE ENCLOSURE HAS PHYSICAL DAMAGE AND NEEDS TO BE REPLACED. THE DEVICE FAILED AN O2 LOW FLOW TEST DUE TO A MISALIGNED GRAY REMOVEABLE FOAM DURING EVALUATION. THE FOAM WAS READJUSTED AND PASSED TESTING. ADDITIONALLY, THE SEAM GASKET, RUBBER FEET, FRONT AND REAR ENCLOSURE, ENCLOSURE GAP, AND HANDLE NEED TO BE REPLACED. A REPAIR QUOTE WAS SENT TO THE CUSTOMER AND IS AWAITING APPROVAL IN ORDER TO PROCEED WITH THE REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23941016 ↗
• MalfunctionNov 3, 2025Circuit Failure; Mechanical Problem; Failure to Recalibrate; Circuit Failure; Mechanical Problem; Failure to Recalibrate

  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 DEVICE FAILED A TEST STEP DURING TESTING FOR LOW OXYGEN FLOW, AND A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S INLET AIR PATH, AIR PATH FOAM, FLOW PATH AND POWER MANAGEMENT BOARD WERE REPLACED TO ADDRESS THE ISSUES. THE DEVICE PASSED ALL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23445440 ↗
• MalfunctionOct 28, 2025Circuit Failure; Failure to Recalibrate; Circuit Failure; Failure to Recalibrate

  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 DEVICE FAILED TEST STEPS DURING TESTING FOR LOW OXYGEN FLOW AND POSITIVE FLOW VERIFY. THE SENSOR BOARD HAS BEEN REPLACED DUE TO FAILED TEST. THE DEVICE'S INLET AIR PATH, AIR PATH FOAM, AND FLOW PATH WERE REPLACED TO ADDRESS THE ISSUE. UNIT HAS BEEN RECALIBRATED. THE DEVICE PASSED ALL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23408670 ↗
• MalfunctionOct 22, 2025Failure to Recalibrate; Failure to Recalibrate

  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 DEVICE FAILED A TEST STEP DURING TESTING FOR LOW OXYGEN FLOW. THE DEVICE'S INLET AIR PATH, AIR PATH FOAM, AND FLOW PATH WERE REPLACED TO ADDRESS THE ISSUE. THE DEVICE PASSED ALL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23364022 ↗
• MalfunctionOct 17, 2025Failure to Recalibrate; Failure to Recalibrate

  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 DEVICE FAILED A TEST STEP DURING TESTING FOR LOW OXYGEN FLOW. THE DEVICE'S INLET AIR PATH, AIR PATH FOAM, AND FLOW PATH WERE REPLACED TO ADDRESS THE ISSUE. THE SERVICE TECHNICIAN DETERMINED ADJUSTMENT OF GREY REMOVABLE FOAM IS NECESSARY. THE FOAM WAS ADJUSTED CORRECTLY. THE DEVICE PASSED ALL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23320970 ↗
• MalfunctionOct 16, 2025Failure to Recalibrate; Failure to Recalibrate

  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 DEVICE FAILED A TEST STEP FOR POSITIVE FLOW VERIFY. THE DEVICE WAS RECALIBRATED TO ADDRESS THE ISSUE. ADDITIONAL TESTING WAS PERFORMED FOLLOWING THE DEVICE REPAIR, AND THE DEVICE PASSED ALL FINAL TESTING AND WAS FOUND TO PERFORM TO SPECIFICATIONS AND AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23308444 ↗
• MalfunctionSep 17, 2025Mechanical Problem; Failure to Calibrate; Mechanical Problem; Failure to Calibrate

  A TRILOGY 100 VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF PATIENT HARM. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. THE TRILOGY 100 DEVICE FAILED A 02 LOW FLOW TEST STEP DURING EVALUATION AT THE MANUFACTURER'S SERVICE CENTER. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE (AECM) TO ADDRESS THE ISSUE. NO REPAIR WAS PERFORMED. THE UNIT IS NOT NEEDED FOR INVENTORY, AND IT WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23077183 ↗
• MalfunctionSep 12, 2025Failure to Recalibrate; Failure to Recalibrate

  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 DEVICE FAILED A TEST STEP FOR OXYGEN LOW FLOW. THE SERVICE TECHNICIAN DETERMINED ADJUSTMENT OF GREY REMOVABLE FOAM IS NECESSARY. THE FOAM WAS ADJUSTED CORRECTLY. ADDITIONAL TESTING WAS PERFORMED FOLLOWING THE DEVICE REPAIR, AND THE DEVICE PASSED ALL FINAL TESTING AND WAS FOUND TO PERFORM TO SPECIFICATIONS AND AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23044276 ↗
• MalfunctionJun 17, 2025Battery Problem; Battery Problem

  A TRILOGY 100 VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER A VENTILATOR SERVICE REQUIRED AN ERROR CODE RELATED TO THE CHARGING OF THE INTERNAL BATTERY. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE COMPLAINT WAS CONFIRMED DURING THE DEVICE'S EVALUATION AT THE MANUFACTURER'S SERVICE CENTER. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S INTERNAL BATTERY TO ADDRESS THE INTERNAL BATTERY ERROR CODE. THE DEVICE WAS SCRAPPED. NO REPAIR WAS PERFORMED. THE DEVICE IS NOT NEEDED FOR INVENTORY AND WAS SCRAPPED. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235654 ↗
• MalfunctionMay 6, 2025Failure to Calibrate; Failure to Calibrate

  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 DEVICE FAILED A TEST STEP DURING TESTING. THE DEVICE'S GREY REMOVABLE FOAM WAS PROPERLY RE-INSTALLED ON THE DEVICE TO ADDRESS THE ISSUE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE WAS RUBBER FEET MISSING FROM THE DEVICE. THE RUBBER FEET WERE REPLACED TO ADDRESS THIS ISSUE. AFTERWARDS, THE DEVICE WAS TESTED AGAIN AND PASSED ALL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971646 ↗
• MalfunctionMay 6, 2025Degraded; Improper Flow or Infusion; Degraded; Improper Flow or Infusion

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS NOT DELIVERING THE SET PRESSURE. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND VISIBLE FOAM PARTICLES WERE NOTED IN THE AIRPATH. THE DEVICES SOUND ABATEMENT FOAM NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. NO REPAIR PERFORMED DUE TO THE DEVICE NOT NEEDED FOR INVENTORY. THE UNIT WILL BE SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965685 ↗
• MalfunctionApr 23, 2025No Display/Image; No Display/Image

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S LCD SCREEN WAS BLANK. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE, THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S SYSTEM BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, THE DEVICE'S REAR ENCLOSURE WAS FOUND TO BE PHYSICALLY DAMAGED AND NEEDS REPLACED. NO REPAIRS WERE PERFORMED. THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21890818 ↗
• MalfunctionApr 17, 2025Failure to Power Up; Failure to Power Up

  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 DEVICE'S INITIAL POWER UP ISSUE WAS OBSERVED. THE DEVICE'S INTERFACE PCA NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. NO REPAIRS PERFORMED. THE UNIT WILL BE SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21855620 ↗
• MalfunctionMar 17, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE FOR EVALUATION OF A BROKEN NURSE CALL CONNECTOR. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE ALLEGED BROKEN NURSE CALL CONNECTOR WAS CONFIRMED. THE NURSE CALL CONNECTOR REQUIRED REPLACEMENT TO ADDRESS THE ISSUE. HOWEVER, THE DEVICE WAS NOT REQUIRED FOR INVENTORY AND WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21621771 ↗
• MalfunctionMar 6, 2025Failure to Recalibrate; Failure to Recalibrate

  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 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 21533952 ↗
• MalfunctionMar 5, 2025No Display/Image; No Display/Image

  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 DEVICE'S SCREEN WAS UNREADABLE. NO REPAIRS PERFORMED. THE UNIT WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21524225 ↗
• MalfunctionFeb 19, 2025Degraded; Degraded

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR A BLUETOOTH UPGRADE. 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, PARTICLES WERE VERIFIED IN THE AIRPATH. THE UNIT IS NOT NEEDED FOR INVENTORY AND WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21416230 ↗
• MalfunctionFeb 4, 2025Battery Problem; Battery 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 VENTILATOR INOPERATIVE ALARM CONDITION WAS OBSERVED. THE DEVICE'S INTERNAL BATTERY NEEDS TO BE REPLACED. NO COMPONENTS WERE REPLACED. THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21305209 ↗
• MalfunctionJan 29, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property 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, MULTIPLE VENTILATOR SERVICE REQUIRED ERROR CODES WERE FOUND IN THE DEVICE'S ERROR LOG. THE SYSTEM AND CENTRAL PROCESSING UNIT BOARD NEED TO BE REPLACED TO RESOLVE THE ISSUE. NO REPAIRS WERE PERFORMED. THE UNIT HAS BEEN SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21270484 ↗

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-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-0884-2023 · Dec 7, 2022 · Open, Classified
  Philips Garbin Ventilator, Model Number 1058180B
• 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