BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL

    MDR report key: 3779636 · Received April 22, 2014

    Report

    Report Number
    3779636
    Event Type
    Injury
    Date Received
    April 22, 2014
    Date of Event
    March 28, 2014
    Report Date
    April 22, 2014
    Manufacturer
    ZOLL MEDICAL CORP
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING CPR ON A CARDIAC ARREST PT THE ZOLL MONITOR WAS CHARGED TO 200 JOULES, THE SHOCK BUTTON WAS PRESSED AND THE MONITOR MADE "BONKING" SOUND. THEIR WAS NO EVIDENCE THE PT RECEIVED A SHOCK. THIS WAS REPEATED ONE MORE TIME AND WITH THE SAME RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244521 ZOLL ZOLL X SERIES MKJ ZOLL MEDICAL CORP X SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening| O