BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE

    MDR report key: 19885609 · Received August 1, 2024

    Report

    Report Number
    3003521780-2024-00650
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Date of Event
    May 22, 2024
    Report Date
    May 24, 2024
    Manufacturer
    DEFIBTECH LLC
    Product Code
    DRM
    PMA / PMN Number
    K211289
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH REQUESTED, THE CHEST COMPRESSOR HAS NOT BEEN RETURNED AND THE CAUSE OF THE COMPLAINT IS NOT KNOWN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR SHALL BE SUBMITTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE CARDIAC COMPRESSOR FAILED DURING USE. NO SPECIFICS REGARDING THE TYPE OF FAILURE WERE PROVIDED. THEY REPORTED THAT RETURN OF SPONTANEOUS CIRCULATION (ROSC) WAS ACHIEVED PRIOR TO ARRIVAL AT THE ER BUT LOST ENROUTE AND THAT THE PATIENT SURVIVED TO HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164863 LIFELINE CARDIAC COMPRESSOR DRM DEFIBTECH LLC RMU-2000

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male