BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFIBTECH AUTOMATIC COMPRESSION DEVICE

    MDR report key: 24955233 · Received April 22, 2026

    Report

    Report Number
    MW5187160
    Event Type
    Injury
    Date Received
    April 22, 2026
    Date of Event
    April 13, 2026
    Report Date
    April 17, 2026
    Manufacturer
    DEFIBTECH, LLC.
    Product Code
    DRM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DEFIBTECH AUTOMATIC CPR (CARDIOPULMONARY RESUSCITATION) DEVICE WAS PLACED ON THE PATIENT BY EMS (EMERGENCY MEDICAL SERVICES) IN THE FIELD WITH A PROLONGED CODE. UPON ARRIVAL THE EMERGENCY DEPARTMENT, IT WAS DISCOVERED THAT THE DEVICE CAUSED A PENETRATING CHEST WOUND TO THE PATIENT. THE PATIENT ULTIMATELY DIED DUE TO ANOXIC BRAIN INJURY AND PROLONGED ARREST. I AM REPORTING THIS INCIDENT AS THE HOSPITAL PATIENT SAFETY OFFICER. THE EMS COMPANY THAT OWNS AND OPERATES THIS EQUIPMENT IS (B)(6). (B)(6) IS THE EMS DIRECTOR AND SHOULD HAVE THE SPECIFIC MODEL/PRODUCT INFORMATION IF NEEDED. PT: 1762, 2219, 4559. DEVICE: 4001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010314 DEFIBTECH AUTOMATIC COMPRESSION DEVICE COMPRESSOR, CARDIAC, EXTERNAL DRM DEFIBTECH, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Other