BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY100

    MDR report key: 15925839 · Received December 6, 2022

    Report

    Report Number
    2518422-2022-101094
    Event Type
    Malfunction
    Date Received
    December 6, 2022
    Date of Event
    November 8, 2022
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959025387
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED ON THIS DEVICE IN MDR 2518422-2022-100304. THIS REPORT WAS SUBMITTED AS A DUPLICATE REPORT OF THE PREVIOUSLY SUBMITTED REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING SMOKE WAS EMITTING FROM A VENTILATOR. THE DEVICE WAS POWERED OFF AND THEN WAS DIFFICULT TO POWER ON. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT 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
    308313 TRILOGY100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054655 00606959025387

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown