Trilogy Trilogy 100 Ventilator, BrazilRecalls & reported problems

Summary

The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 00606959022775), received between Oct 7, 2015 and Jul 1, 2026 — classified as 2 deaths, 124 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (18 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 127 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2026Electrical /Electronic Property Problem

  A TRILOGY 100 WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO EVIDENCE THE DEVICE WAS IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION HOWEVER, A VENTILATOR INOPERATIVE ERROR CODE INDICATING THE DEVICE IS UNABLE TO BE POWERED ON WAS OBSERVED. THERE WAS NO DOCUMENTATION OF ANY COMPONENT BEING REPLACED TO ADDRESS THE ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE THAT CHANGES THE OUTCOME OF THE INVESTIGATION AND ASSOCIATED MEDICAL DEVICE REPORTING A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25676695 ↗
• MalfunctionJun 23, 2026Electrical /Electronic Property Problem

  A TRILOGY 100 VENTILATOR DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO ALLEGATION OF PATIENT HARM. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION, R VENTILATOR SERVICE REQUIRED ERROR CODES E106 (SPEAKER 1 FAILURE) AND E107 (SPEAKER 2 FAILURE) WERE IDENTIFIED IN THE ERROR LOG. THEREFORE, BOTH SPEAKERS HAD FAILED. NO DOCUMENTATION OF A REPLACED COMPONENT TO ADDRESS THE ISSUE. ADDITIONALLY, NO VISIBLE FOAM PARTICLES WERE VISUALIZED. THE DEVICE LOG IDENTIFIED ADDITIONAL R VENTILATOR SERVICE REQUIRED ERROR CODES E147 (ERR_DRIFT_PROX_PRESSURE_TOO_HIGH) AND E197 (ERR_INT_LI_ION_NOT_PRESENT). A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE, A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25598028 ↗
• MalfunctionJun 8, 2026Failure to Power Up

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY 100 VENTILATOR WAS RETURNED FOR EVALUATION. NO PATIENT INJURY OR SERIOUS HARM WAS REPORTED. THE DEVICE WAS EVALUATED AT A MANUFACTURER SERVICE CENTER. A VISUAL INSPECTION WAS PERFORMED, AND NO EVIDENCE OF FOAM PARTICLES OR FOAM DEGRADATION WAS OBSERVED. THE DEVICE WAS UNABLE TO READ DATA AND WOULD NOT POWER ON. NO DOCUMENTATION REGARDING PRIOR COMPONENT REPLACEMENT WAS AVAILABLE. NO REPAIR ACTIVITIES WERE PERFORMED, AND 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 25433376 ↗
• MalfunctionJun 8, 2026Failure to Power Up

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY 100 VENTILATOR WAS RETURNED FOR EVALUATION. NO PATIENT INJURY OR SERIOUS HARM WAS REPORTED. THE DEVICE WAS EVALUATED AT A MANUFACTURER SERVICE CENTER. A VISUAL INSPECTION WAS PERFORMED, AND NO EVIDENCE OF FOAM PARTICLES OR FOAM DEGRADATION WAS OBSERVED. THE DEVICE WAS UNABLE TO READ DATA AND WOULD NOT POWER ON. NO DOCUMENTATION REGARDING PRIOR COMPONENT REPLACEMENT WAS AVAILABLE. NO REPAIR ACTIVITIES WERE PERFORMED, AND 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 25431963 ↗
• MalfunctionJun 8, 2026Failure to Power Up

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY 100 VENTILATOR WAS RETURNED FOR EVALUATION. NO PATIENT INJURY OR SERIOUS HARM WAS REPORTED. THE DEVICE WAS EVALUATED AT A MANUFACTURER SERVICE CENTER. A VISUAL INSPECTION WAS PERFORMED, AND NO EVIDENCE OF FOAM PARTICLES OR FOAM DEGRADATION WAS OBSERVED. THE DEVICE WAS UNABLE TO READ DATA AND WOULD NOT POWER ON. NO DOCUMENTATION REGARDING PRIOR COMPONENT REPLACEMENT WAS AVAILABLE. NO REPAIR ACTIVITIES WERE PERFORMED, AND 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 25431950 ↗
• MalfunctionJun 8, 2026Failure to Power Up

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY 100 VENTILATOR WAS RETURNED FOR EVALUATION. NO PATIENT INJURY OR SERIOUS HARM WAS REPORTED. THE DEVICE WAS EVALUATED AT A MANUFACTURER SERVICE CENTER. A VISUAL INSPECTION WAS PERFORMED, AND NO EVIDENCE OF FOAM PARTICLES OR FOAM DEGRADATION WAS OBSERVED. THE DEVICE WAS UNABLE TO READ DATA AND WOULD NOT POWER ON. NO DOCUMENTATION REGARDING PRIOR COMPONENT REPLACEMENT WAS AVAILABLE. NO REPAIR ACTIVITIES WERE PERFORMED, AND 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 25431190 ↗
• MalfunctionJun 8, 2026Failure to Power Up

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY 100 VENTILATOR WAS RETURNED FOR EVALUATION. NO PATIENT INJURY OR SERIOUS HARM WAS REPORTED. THE DEVICE WAS EVALUATED AT A MANUFACTURER SERVICE CENTER. A VISUAL INSPECTION WAS PERFORMED, AND NO EVIDENCE OF FOAM PARTICLES OR FOAM DEGRADATION WAS OBSERVED. THE DEVICE WAS UNABLE TO READ DATA AND WOULD NOT POWER ON. NO DOCUMENTATION REGARDING PRIOR COMPONENT REPLACEMENT WAS AVAILABLE. NO REPAIR ACTIVITIES WERE PERFORMED, AND 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 25431179 ↗
• MalfunctionMay 20, 2026Failure to Power Up

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY 100 VENTILATOR WAS RETURNED FOR EVALUATION. NO PATIENT INJURY OR SERIOUS HARM WAS REPORTED. THE DEVICE WAS EVALUATED AT A MANUFACTURER SERVICE CENTER. A VISUAL INSPECTION WAS PERFORMED, AND NO EVIDENCE OF FOAM PARTICLES OR FOAM DEGRADATION WAS OBSERVED. THE DEVICE WAS UNABLE TO READ DATA AND WOULD NOT POWER ON. NO DOCUMENTATION REGARDING PRIOR COMPONENT REPLACEMENT WAS AVAILABLE. NO REPAIR ACTIVITIES WERE PERFORMED, AND 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 25229623 ↗
• MalfunctionMar 10, 2026Failure to Power Up

  THE MANUFACTURER RECEIVED INFORMATION A TRILOGY 100 VENTILATOR WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS EVALUATED AND CONFIRMED NO FOAM PARTICLES VISUALIZED INSIDE THE DEVICE. ON TESTING, THE VENTILATOR FAILED TO POWER ON; THE DEVICE DID NOT READ THE DATA. IT WAS REPORTED THAT THE DEVICE WAS SCRAPPED WITH NO FURTHER EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558133 ↗
• MalfunctionJan 8, 2026Circuit Failure; Mechanical Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO EVIDENCE THE DEVICE WAS IN PATIENT USE. DURING THE EVALUATION A VENTILATOR INOPERATIVE ALARM CONDITION WAS OBSERVED. THE DEVICE'S MOTOR BLOWER, EXHAUST FAN AND POWER MANAGEMENT BOARD WERE REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS TESTED AND PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24001867 ↗
• MalfunctionDec 30, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE TRILOGY 100 VENTILATOR WAS RETURNED TO THE THIRD PARTY FOR SERVICE. THE DEVICE WAS NOT REPORTED TO BE IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION OF THE DEVICE AT A THIRD-PARTY SERVICE CENTER SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION HOWEVER, A VENTILATOR INOPERATIVE ERROR CODE INDICATING (MOTOR FAILURE) WAS CONFIRMED IN THE EVENT LOG. THE DEVICE SOFTWARE WAS UPGRADED. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921542 ↗
• MalfunctionOct 28, 2025Electrical /Electronic Property Problem; Mechanical Problem; Electrical /Electronic Property Problem; Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED ERROR HAD OCCURRED 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 EVALUATED AT THE THIRD-PARTY SERVICE CENTER FOR THIS ISSUE. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE, VLI ION FAILURE (E-199), WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE TECHNICIAN EVALUATED AND DETERMINED THE BLOWER MOTOR ASSEMBLY HAD LED TO THE ERROR CODE TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S BLOWER MOTOR ASSEMBLY WAS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23401676 ↗
• MalfunctionOct 27, 2025Electrical /Electronic Property Problem; Mechanical Problem; Electrical /Electronic Property Problem; Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE ERROR HAD OCCURRED 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 EVALUATED AT THE THIRD-PARTY SERVICE CENTER FOR THIS ISSUE. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE, DSP MOTOR FAILURE (E-009), WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE TECHNICIAN EVALUATED AND DETERMINED THE BLOWER MOTOR ASSEMBLY HAD LED TO THE ERROR CODE TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S BLOWER MOTOR ASSEMBLY WAS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23398855 ↗
• MalfunctionOct 27, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATION INOPERATIVE ERROR CODE WAS FOUND 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 EVALUATED AT A THIRD-PARTY SERVICE CENTER. DURING THE EVALUATION IT WAS NOTED THAT THE ERROR CODE, DSP MAXIMUM HOST REBOOTS (E-037) WAS OBSERVED IN THE DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE TECHNICIAN EVALUATED AND DETERMINED THE BLOWER MOTOR ASSEMBLY, BATTERY FAN, AND INLET AIR PATH FOAM HAD CAUSED THE ISSUE TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S BLOWER MOTOR ASSEMBLY, BATTERY FAN, AND INLET AIR PATH FOAM WERE REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23398654 ↗
• MalfunctionJun 2, 2025Mechanical Problem; Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE ERROR CODE RELATED TO THE MOTOR FAILURE AND A VENTILATOR INOPERATIVE ERROR CODE OF ERR_DSP_MAX_HOST_REBOOTS OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE MOTOR BLOWER ASSEMBLY, THE BATTERY FAN AND THE STIRRING FAN RETAINER WERE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125585 ↗
• MalfunctionJun 2, 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, VENTILATOR SERVICE REQUIRED ERROR CODES RELATED TO THE CONTROL PRESSURE SENSOR AND THE AIRSTREAM TEMPERATURE SENSOR WERE FOUND. ERR_CONTROL_PRESS_RAILED MEANS THE CONTROL PRESSURE SENSOR IS READING MAXIMUM OR MINIMUM COUNTS FOR AN EXTENDED PERIOD OF TIME. ERR_AIRSTREAM_TEMP_1_RAILED MEANS THE AIRSTREAM TEMPERATURE SENSOR IS READING MAXIMUM OR MINIMUM COUNTS FOR AN EXTENDED PERIOD OF TIME. THE BATTERY FAN WAS LISTED AS BEING REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, A VENTILATOR SERVICE REQUIRED ERROR CODE RELATED TO THE MONITOR PRESSURE SENSOR WAS FOUND. ERR_MONITOR_PRESS_RAILED MEANS THE MONITOR PRESSURE SENSOR IS READING MAXIMUM OR MINIMUM COUNTS FOR AN EXTENDED PERIOD OF TIME. THIS ERROR IS NOT CONSIDERED A REPORTABLE MALFUNCTION/ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125145 ↗
• MalfunctionMay 31, 2025Failure to Sense; Failure to Sense

  A TRILOGY 100 VENTILATOR WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO REPORTED PATIENT INVOLVEMENT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD PARTY SERVICE CENTER, A PROXIMAL FLOW SENSOR FAILURE ERROR CODE WAS FOUND IN THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN STATES THAT THE TRILOGY MOTOR BLOWER ASSEMBLY KIT WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE PASSED ALL FINAL TESTING. NO FURTHER INVESTIGATION IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22120460 ↗
• MalfunctionApr 18, 2025Device Sensing Problem; Device Sensing Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, "VENTILATOR SERVICE REQUIRED" ERROR CODES RELATED TO SENSING ISSUES WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THERE IS NO DOCUMENTATION WHAT COMPONENT NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. ADDITIONALLY, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, NO FOAM PARTICLES WERE OBSERVED. THE DEVICE HAS BEEN REMEDIATED, AND THE SOFTWARE HAS BEEN UPGRADED. THE DEVICE DID NOT PASS FINAL TESTING. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE FOLLOWING THE COMPLETION OF THE DEVICE REPAIR THAT CHANGES THE OUTCOME OF THE INVESTIGATION AND ASSOCIATED MEDICAL DEVICE REPORTING A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865131 ↗
• MalfunctionApr 18, 2025Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, CRITICAL ERROR CODES RELATING TO SPEAKER 1 AND SPEAKER 2 FAILURE WAS OBSERVED. THERE IS NO DOCUMENTATION IN THE REPAIR EVALUATION WHAT COMPONENT(S) NEED TO BE REPLACED TO ADDRESS THE ISSUE. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. ADDITIONALLY, THE DEVICE HAS BEEN VISUALLY INSPECTED AND NO VISIBLE EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, NO FOAM PARTICLES WERE OBSERVED. THE DEVICE HAS BEEN REMEDIATED, REPAIRED; SOFTWARE UPDATED AND PASSED ALL FINAL TESTING. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE FOLLOWING THE COMPLETION OF THE DEVICE REPAIR THAT CHANGES THE OUTCOME OF THE INVESTIGATION AND ASSOCIATED MEDICAL DEVICE REPORTING A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865129 ↗
• MalfunctionApr 18, 2025Power Problem; Power Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, AN ERROR CODE RELATED TO A PERMANENT FAILURE OF THE INTERNAL BATTERY FAULT WAS OBSERVED. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S MOTOR BLOWER ASSEMBLY TO ADDRESS THE ISSUE. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. ADDITIONALLY, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, NO FOAM PARTICLES WERE OBSERVED. THE DEVICE HAS BEEN REMEDIATED; THE SOFTWARE HAS BEEN UPGRADED AND PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21864839 ↗
• MalfunctionApr 18, 2025Power Problem; Power Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE INITIAL EVALUATION THE DEVICE DID NOT MEET ACCEPTANCE CRITERIA OF EVALUATION PROCESS FOR NO POWER. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S POWER SUPPLY TO ADDRESS THE ISSUE. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. ADDITIONALLY, THE DEVICE'S OXYGEN CONNECTOR WAS REPLACED DUE TO BEING BROKEN. DURING THE EVALUATION OF THE DEVICE, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, NO FOAM PARTICLES WERE OBSERVED. THE DEVICE HAS BEEN REMEDIATED, REPAIRED, THE SOFTWARE UPGRADED AND PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21864837 ↗
• MalfunctionFeb 26, 2025Electrical /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, THE DEVICE WAS FOUND TO HAVE AN INOPERATIVE BLOWER AND LEAKY FLOW SENSOR. THE DEVICE WAS REWORKED TO ADDRESS THE ISSUES AND PASSED FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471160 ↗
• MalfunctionFeb 21, 2025Unexpected Shutdown; Unexpected Shutdown

  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 ERROR CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. 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 21432622 ↗
• MalfunctionJan 21, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A VENTILATOR WAS RETURNED TO THE DISTRIBUTOR FOR SERVICE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. DURING INITIAL EVALUATION OF THE DEVICE AT THE DISTRIBUTOR, A VENTILATOR INOPERATIVE AND SERVICE REQUIRED ALARM CONDITIONS WERE OBSERVED. THE DEVICE¿S MOTOR BLOWER AND FLOW SENSOR WERE REPLACED TO ADDRESS THE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21197342 ↗
• MalfunctionJan 17, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS NOTIFICATION WAS OPENED FOR REVIEW DUE TO THE MANUFACTURER BEING CONTACTED ABOUT THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE DEVICE EVALUATION, NO EVIDENCE OF FOAM WAS FOUND. HOWEVER, UPON REVIEW OF THE ERROR LOGS, THERE WAS A FAILURE IN THE BATTERY THAT MAY IMPACT THERAPY TO THE SPECIFIED PUBLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21185959 ↗

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