Trilogy100 Ventilator, Japan-RentalRecalls & reported problems

Summary

The FDA's MAUDE database contains 334 adverse event reports that list this exact device (DI 00606959033894), received between Sep 26, 2016 and May 2, 2025 — classified as 2 deaths, 4 injuries, 327 malfunctions.

The most frequently reported specific device problem is “Incorrect Or Inadequate Test Results” (110 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 334 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property 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, AN ERROR CODE RELATED TO THE TEMPERATURE OF THE INTERNAL BATTERY WAS OBSERVED. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE MANUFACTURER¿S SERVICE TECHNICIAN OBSERVED ERROR CODE E-246 (INTERNAL BATTERY) IN THE DEVICE¿S EVENT LOG. THE SERVICE TECHNICIAN REPLACED THE DEVICE¿S POWER MANAGEMENT PRINTED CIRCUIT ASSEMBLY BOARD TO ADDRESS E-246. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE WAS THE FOLLOWING PARTS WERE PROACTIVELY REPLACED ON THE DEVICE: POLLEN FILTER, EXHAUST FAN ASSEMBLY, AND 43-MICRON FILTER. AFTER THE PARTS WERE REPLACED ON THE DEVICE, THE MANUFACTURER¿S SERVICE TECHNICIAN PERFORMED THE REPAIR AND RUN-IN TESTS, ALONG WITH THE BATTERY AND VALVE CHECKS. THE MANUFACTURER¿S SERVICE TECHNICIAN DETERMINED THE DEVICE WAS OPERATIONAL, AND IT WAS CLEANED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953627 ↗
• MalfunctionJul 1, 2024No Display/Image; No Display/Image

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT THE SCREEN DID NOT DISPLAY DURING A TEST RUN. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE ISSUE THAT THE SCREEN WAS NOT DISPLAYED WAS NOT CONFIRMED, AND IT WAS OBSERVED THAT THE SCREEN WAS READABLE. THERE WERE NO ERRORS INDICATING ABNORMALITIES IN THE DEVICE RECORDED ON THE ERROR LOG. IT IS DETERMINED THAT THIS ISSUE WAS CAUSED BY A MALFUNCTION OF THE LCD. THE LCD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643183 ↗
• MalfunctionJul 1, 2024No Display/Image; No Display/Image

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT THE SCREEN DID NOT DISPLAY DURING A TEST RUN. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING AN OPERATIONAL CHECK, THE ISSUE THAT THE SCREEN WAS NOT DISPLAYED AND WAS UNABLE TO READ THE DISPLAYED CONTENT WAS DUPLICATED. IT IS DETERMINED THAT THIS ISSUE WAS CAUSED BY A MALFUNCTION OF THE LCD. THE DEVICE¿S LCD DISPLAY WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643170 ↗
• MalfunctionJun 21, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property 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, AN ERROR CODE RELATED TO THE CHARGING OF THE INTERNAL BATTERY WAS OBSERVED. THE DEVICE'S INTERNAL BATTERY NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. HOWEVER, SINCE THE END OF THE LEASE TERM IS 09/25/2026, PERIODIC MAINTENANCE AND REPAIR WERE CANCELED. NO REPAIR WAS PERFORMED ON THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19584853 ↗
• MalfunctionJun 20, 2024Battery 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, AN ERROR CODE RELATED TO THE CHARGING OF THE INTERNAL BATTERY WAS OBSERVED. THE DEVICE WILL BE RETURNED DISPOSED OF WITHOUT REPAIR DUE TO LEASED UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19576644 ↗
• MalfunctionJun 18, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property 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, AN ERROR CODE RELATED TO THE INTERNAL BATTERY DEPLETED WAS OBSERVED. THE DEVICE'S POWER MANAGEMENT BOARD WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, NOT RELATED TO THE ISSUE NOISE WAS COMING FROM THE MOTOR BLOWER ASSEMBLY. THEREFORE, THE MOTOR BLOWER ASSEMBLY WAS REPLACED. THE FRONT ENCLOSURE OVERLAY WAS REPLACED DUE TO SCRATCHES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558825 ↗
• MalfunctionJun 18, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property 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, AN ERROR CODE RELATED TO THE CHARGING OF THE INTERNAL BATTERY WAS OBSERVED. THE DEVICE'S POWER MANAGEMENT BOARD WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, NOT RELATED TO THE ISSUE THE FLOW SENSOR ASSEMBLY AND MOTOR BLOWER ASSEMBLY DUE TO TOBACCO SMELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558565 ↗
• MalfunctionJun 18, 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, A FAILURE OF THE DEVICE'S LCD SCREEN WAS OBSERVED. THE DEVICE¿S LCD DISPLAY WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, DIRT WAS CONFIRMED ON THE FLOW SENSOR ASSEMBLY, AND IT WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558564 ↗
• MalfunctionJun 12, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CHECK CIRCUIT ALARM OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED IN THE DEVICE'S EVENT LOG. SINCE A TEMPORAL FAILURE IN ACTIVE EXHALATION CONTROL MODULE WAS CONSIDERED AS THE CAUSE OF THE OCCURRENCE, THE ACTIVE EXHALATION CONTROL MODULE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19522214 ↗
• MalfunctionJun 10, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property 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, AN "INTERNAL BATTERY" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S POWER MANAGEMENT BOARD WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE WERE THE POLLEN FILTER, EXHAUST FAN ASSEMBLY, 43-MICRON FILTER WERE PROACTIVELY REPLACED ON THE DEVICE. AFTER REPLACING THE PARTS ON THE SYSTEM, THE REPAIR TEST AND RUNNING TEST, BATTERY AND VALVE CHECKS, AND A CLEANING OF THE DEVICE WERE PERFORMED. THE DEVICE WAS FOUND TO BE OPERATIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19502941 ↗
• MalfunctionJun 7, 2024Failure 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 FINAL EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED THE ACTIVE EXCHANGE PROPORTIONAL VALVE TEST DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE WAS A NOISE COMING FROM THE MOTOR BLOWER ASSEMBLY. THE MOTOR BLOWER ASSEMBLY WAS REPLACED ALONG WITH THE STIRRING FAN FOAM. AFTER THE PARTS WERE REPLACED ON THE DEVICE, THE REPAIR AND RUN-IN TESTS, A BATTERY AND ALARM CHECKS, AND A CLEANING OF THE DEVICE WERE PERFORMED. THE DEVICE WAS FOUND TO BE OPERATIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19488789 ↗
• MalfunctionJun 7, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property 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, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19485131 ↗
• MalfunctionJun 5, 2024Failure 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 ACTIVE EXHALATION SOLENOID VALVE TEST FAILED ON THE DEVICE. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE. AFTER REPLACING THE PART ON THE DEVICE, THE REPAIR AND RUNNING TEST WERE PERFORMED, ALARM AND BATTERY CHECKS, AND THE DEVICE WAS FOUND TO BE OPERATIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19470980 ↗
• MalfunctionMar 6, 2024Electrical /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, 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. ADDITIONALLY, THE KEYPAD WAS ALSO REPLACED, WHICH WAS NOT RELATED TO THE MALFUNCTION/ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18844696 ↗
• MalfunctionMar 5, 2024Circuit Failure; Battery Problem; Circuit Failure; 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 SERVICE REQUIRED CODE RELATED TO THE CHARGING OF THE INTERNAL BATTERY WAS OBSERVED. THE DEVICE'S POWER MANAGEMENT BOARD AND INTERNAL BATTERY NEED TO BE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18842586 ↗
• MalfunctionFeb 5, 2024Electrical /Electronic Property Problem; Battery Problem; Electrical /Electronic Property Problem; Battery Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE 1. 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, AN ERROR CODE RELATED TO THE CHARGING OF THE INTERNAL BATTERY WAS OBSERVED. SINCE THE EVENT LOG VERIFIED THAT THE ERROR HAD OCCURRED DURING RUNNING ON AC POWER WITH THE INTERNAL BATTERY CAPACITY HAVING BEEN 97%, THE POWER MANAGEMENT BOARD AND INTERNAL BATTERY WERE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18639692 ↗
• MalfunctionJan 2, 2024Mechanical Problem; Battery Problem; Mechanical 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, AN ERROR CODE RELATED TO THE CHARGING OF THE INTERNAL BATTERY WAS OBSERVED. THE DEVICE'S POWER MANAGEMENT BOARD WAS REPLACED TO ADDRESS THE ISSUE. DAMAGE TO THE SCREW RECEIVING PART OF THE REAR AND FRONT ENCLOSURE WAS CONFIRMED, THE REAR AND FRONT ENCLOSURE WAS REPLACED. DAMAGE WAS CONFIRMED, THE FLOW SENSOR ASSEMBLY WAS REPLACED. THE DEVICE PASSED FINAL TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18428568 ↗
• MalfunctionMar 7, 2022Degraded; Degraded

  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 AIR PATH FOAM, STIRRING FAN, AND FLOW SENSOR ASSEMBLY WERE REPLACED DUE TO PREVENTATIVE MAINTENANCE. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13685192 ↗
• MalfunctionMar 7, 2022Degraded; Degraded

  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 BLOWER, STIRRING FAN, AND AIR INLET PATH FOAM WERE REPLACED DUE TO PREVENTATIVE MAINTENANCE. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13685172 ↗
• MalfunctionMar 3, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BACTERIA FILTER WAS TURNING BLACK AFTER USE. THERE WAS NO PATIENT HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE AIR PATH ASSEMBLY, BLOWER, FLOW SENSOR ASSEMBLY, TUBING KIT AND ACTIVE EXHALATION CONTROL MODULE WERE REPLACED DUE TO BLACK POWDER, SOOT-LIKE CONTAMINATION. THE STIRRING FAN FOAM WAS REPLACED DUE TO PREVENTATIVE MAINTENANCE. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13663952 ↗
• MalfunctionMar 2, 2022Degraded; Degraded

  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 AIR INLET PATH ASSEMBLY, BLOWER, STIRRING FAN, FLOW SENSOR ASSEMBLY AND STIRRING FAN FOAM WERE REPLACED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13653901 ↗
• MalfunctionMar 2, 2022Degraded; Degraded

  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 AIR INLET PATH ASSEMBLY WAS REPLACED TO PREVENT FOAM DEGRADATION FAILURE. THE BLOWER, STIRRING FAN, STIRRING FAN FOAM AND FLOW SENSOR ASSEMBLY WERE REPLACED DUE TO PREVENTATIVE MAINTENANCE. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13653827 ↗
• MalfunctionMar 2, 2022Degraded; Degraded

  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 AIR INLET PATH ASSEMBLY WAS REPLACED TO PREVENT FOAM DEGRADATION. THE STIRRING FAN FOAM, FLOW SENSOR ASSEMBLY AND STIRRING FAN WERE REPLACED DUE TO PREVENTATIVE MAINTENANCE. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13653805 ↗
• MalfunctionMar 1, 2022Degraded; Degraded

  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 BLOWER, STIRRING FAN FOAM AND INLET AIR PATH ASSEMBLY WERE REPLACED DUE TO PREVENTATIVE MAINTENANCE. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13638860 ↗
• MalfunctionMar 1, 2022Degraded; Degraded

  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 AIR INLET PATH ASSEMBLY WAS REPLACED DUE TO SMELL ISSUE AND STIRRING FAN FOAM WAS REPLACED DUE TO PREVENTATIVE MAINTENANCE. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13634472 ↗

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