BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFIBTECH LIFELINE ARM ACC

    MDR report key: 18191854 · Received November 21, 2023

    Report

    Report Number
    MW5148364
    Event Type
    Injury
    Date Received
    November 21, 2023
    Date of Event
    November 18, 2023
    Report Date
    November 18, 2023
    Manufacturer
    DEFIBTECH LLC.
    Product Code
    DRM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CPR(CARDIOPULMONARY RESUSCITATION) MACHINE LEFT A LARGER THAN NORMAL WOUND TO THE PT. THE WOUND APPEARED TO BE DEEPER AND LARGER THAN NORMAL OPERATIONS. PT WAS IN CARDIAC ARREST PRIOR TO USE AND POST USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223143 DEFIBTECH LIFELINE ARM ACC COMPRESSOR, CARDIAC, EXTERNAL DRM DEFIBTECH LLC. RMC-1000 COMPRESSION MODULE

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Other