BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-DETEK

    MDR report key: 209279 · Received February 4, 1999

    Report

    Report Number
    1218058-1999-00001
    Event Type
    Malfunction
    Date Received
    February 4, 1999
    Date of Event
    December 22, 1998
    Report Date
    January 12, 1999
    Manufacturer
    BIO-DETEK, INC.
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE DEFIBRILLATING PT, HEARD A SNAPPING SOUND, LOST RHYTHM ON MONITOR, HAD TO CHANGE PADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-DETEK DEFIBRILLATION ELECTRODES LDD BIO-DETEK, INC. Z 1600 1398

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN