BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL

    MDR report key: 3202356 · Received July 2, 2013

    Report

    Report Number
    3202356
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HOOKED PT UP TO DEFIBRILLATOR; TURNED MACHINE ON AND THE SCREEN DID NOT LIGHT UP; VERIFIED THAT ALL CONNECTIONS WERE INTACT, REMOVED BATTERY, DISCONNECTED CORD FROM ELECTRICAL OUTLET, REPLACED SAME BATTERY AND PURGED BACK INTO OUTLET; SCREEN LIT UP AND PROMPTED A DEFIBRILLATOR CHECK BEFORE USING; CHECK WAS PERFORMED. TURNED ENERGY DOWN TO 30 JOULES, CHANGED MACHINE, ALL CLEAR CALLED AND SHOCK DELIVERED; PT WAS CONNECTED TO THE DEFIBRILLATOR SO PT RECEIVED THE 30 JOULE SHOCK; PT AWARE OF SHOCK, MONITORED PT'S RHYTHM TO NSR. PHYSICIAN NOTIFIED; PROCEEDED E CASE. THE DEVICE HAS BEEN CHECKED EARLIER PER PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302997 ZOLL DEFIBRILLATOR MKJ ZOLL MEDICAL CORP. R SERIES ALS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other