BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL MEDICAL CORP

    MDR report key: 692864 · Received August 2, 2005

    Report

    Report Number
    MW1036257
    Event Type
    Malfunction
    Date Received
    August 2, 2005
    Date of Event
    July 7, 2005
    Report Date
    August 1, 2005
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UNIT IN USE IN EMERGENCY DEPT DURING CODE/ARREST. PT ALSO CONNECTED TO BEDSIDE MONITOR, STAFF COULD HEAR BEEPING OF MONITOR DURING COMPRESSIONS, WHEN STAFF OBSERVED MONITOR NOTES DISPLAY WAS BLANK. SCREEN HAD DISPLAYED WHEN INITIALLY PLACED. UNIT FELT HOT TO TOUCH. UNIT WAS PLUGGED IN ENTIRE TIME IN USE. UNIT SWITCHED OUT IMMEDIATLEY. UNIT WAS < 30 DAYS OF DEPLOYMENT AND TO DEPT. TO BE RETURNED WHEN REPLACEMENT REC'D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOLL MEDICAL CORP DEFIBRILLATOR MONITOR MKJ ZOLL MEDICAL CORPORATION ACLS PLUS *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR