BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL MEDICAL CORPORATION

    MDR report key: 657945 · Received December 23, 2005

    Report

    Report Number
    657945
    Event Type
    Injury
    Date Received
    December 23, 2005
    Date of Event
    December 21, 2005
    Report Date
    December 22, 2005
    Manufacturer
    ZOLL MEDICAL CORP
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A CODE A ZOLL PD1200MFC DEFIBRILLATOR HAD AN UNREADABLE PRINTOUT FOR THE ENTIRE EVENT AND "FIREWORKS" ON THE DISPLAY FOR 10% OF THE EVENT. THE PT WAS SHOCKED AT 200, 300 AND 360 JOULES AND RECOVERED. AFTER THE PT RECOVERED THE NURSE POWER CYCLED THE UNIT AND NOTED THE DATE HAD CHANGED TO 2000. BACKUP DEFIBRILLATOR WAS BROUGHT IN AND USED FOR MONITORING ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOLL MEDICAL CORPORATION DEFIBRILLATOR/PACEMAKER, EXTERNAL (17-88 LDD ZOLL MEDICAL CORP PD1200MFC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening