BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 3713171 · Received March 17, 2014

    Report

    Report Number
    1220908-2014-00626
    Event Type
    Death
    Date Received
    March 17, 2014
    Date of Event
    February 26, 2014
    Report Date
    February 27, 2014
    Manufacturer
    ZOLL MEDICAL CORP
    Product Code
    MKJ
    PMA / PMN Number
    K112432
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT PARAMEDICS RESPONDED TO A CALL FOR A PATIENT (AGE AND GENDER UNK) IN A DRUG OVERDOSE. UPON APPLICATION OF THE DEFIB ELECTRODES, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL. COMPLAINANT INDICATED THAT THE PATIENT WAS TRANSFERRED TO THE HOSPITAL AND SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157416 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORP X SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death