BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 202

    MDR report key: 17931111 · Received October 13, 2023

    Report

    Report Number
    2518422-2023-26301
    Event Type
    Malfunction
    Date Received
    October 13, 2023
    Date of Event
    October 5, 2023
    Report Date
    October 27, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959005150
    PMA / PMN Number
    K093905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED RECEIVING INFORMATION ALLEGING A VENTILATOR WAS OVERHEATING. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND NO EVIDENCE WAS FOUND FOR OVERHEATING ISSUE. THE DEVICE'S BLOWER MOTOR NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. DEVICE PASSED FINAL TEST. IN ADDITION TO THE ABOVE EVALUATION, INSPECTED DEVICE PER PUR PUR5103123 V02; DEVICE HAS DAMAGED FRONT, REAR, AND BASE ENCLOSURES, AS WELL AS A HEAVILY WARPED O2 MANIFOLD. DEVICE DID NOT COME IN WITH A WHISPER CAP, SO I WILL PROVIDE ONE. INCOMING CTQ SCREENING PER 1002735 V19 SHOWS DAMAGED ENCLOSURE SEAL. WHILE REPLACING THE BLOWER MOTOR, THE STIRRING FAN RETAINER SNAPPED OFF. ADDITIONALLY, CONTAMINATION WAS FOUND IN THE FLOW SENSOR ASSEMBLY, 200/202/O2 TUBING, AND EXHAUST FAN. THE POWER SUPPLY HAD A BROKEN PIN, AND BOTH PCB SUPPORT BRACKETS WERE BENT. WHILE REPLACING THE O2 MANIFOLD, IT WAS FOUND THAT THE PRESSURE SENSOR TUBING WAS DAMAGED.WAS FOUND IN THE FLOW SENSOR ASSEMBLY, 200/202/O2 TUBING, AND EXHAUST FAN. THE POWER SUPPLY HAD A BROKEN PIN, AND BOTH PCB SUPPORT BRACKETS WERE BENT. WHILE REPLACING THE O2 MANIFOLD, IT WAS FOUND THAT THE PRESSURE SENSOR TUBING WAS DAMAGED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS OVERHEATING. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631532 TRILOGY 202 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1040007 00606959005150

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown