BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZOLL STAT PADZ

    MDR report key: 34974 · Received July 24, 1996

    Report

    Report Number
    34974
    Event Type
    Death
    Date Received
    July 24, 1996
    Date of Event
    July 23, 1996
    Report Date
    July 23, 1996
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER PT-EXPIRED, PACEMAKER PATCHES WERE (EXTERNAL) REMOVED AND 4 NICKEL AND QUARTER SIZED BURN AREAS FOUND ON SKIN. PACER HAD BEEN AT MAXIMUM MA FOR 8 HOURS. BURN AREAS WITH BROWN RIMS AND WHITE CENTERS. (NECROTIC).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOLL STAT PADZ EXTERNAL PACEMAKER PATCH MLN ZOLL MEDICAL CORP. 8900-4012 1996

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| O