BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 4100959 · Received July 22, 2014

    Report

    Report Number
    1220908-2014-01785
    Event Type
    Death
    Date Received
    July 22, 2014
    Report Date
    July 2, 2014
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K112432
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MED 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 WHILE ATTEMPTING TO MONITOR THE HEART RHYTHM OF A PATIENT (AGE AND GENDER UNK) THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL. COMPLAINANT INDICATED THAT THE PATIENT HAD EXPIRED UPON ARRIVAL TO THE SCENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429411 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death