BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL MEDICAL CORP

    MDR report key: 246273 · Received July 9, 1999

    Report

    Report Number
    MW4002515
    Event Type
    Malfunction
    Date Received
    July 9, 1999
    Date of Event
    May 24, 1999
    Report Date
    July 1, 1999
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DEFIBRILLATOR WAS NEEDED FOR CODE BLUE EVENT. UNIT WAS CHARGED UP TO 360 J AND DELIVERED ENERGY WITHOUT INCIDENT. ATTEMPTED TO CHARGE UNIT UP A SECOND TIME, BUT DEFIBRILLATOR HAD TO BE OBTAINED. UPON RECEIPT OF DEFECTIVE DEFIBRILLATOR BY INHOUSE MAINTENANCE STAFF, DEFIB WAS DISPLAYING ERROR "44." DEFIB IS UNDER WARRANTY AND WAS SENT TO THE MFR FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOLL MEDICAL CORP DEFIBRILLATOR LDD ZOLL MEDICAL CORP. PD-1200 *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR