BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIO-DETEK

    MDR report key: 296548 · Received September 14, 2000

    Report

    Report Number
    1218058-2000-00001
    Event Type
    Death
    Date Received
    September 14, 2000
    Date of Event
    August 17, 2000
    Report Date
    September 13, 2000
    Manufacturer
    BIO-DETEK, INC.
    Product Code
    LDD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PARAMEDIC USING DEFIBRILATOR ON PT WITH Z1600 DEFIB PADS SAW SPARK AND HEARD POPPING SOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-DETEK DEFIBRILLATION ELECTRODES LDD BIO-DETEK, INC. Z1600 2400

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death