BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 3170023 · Received June 5, 2013

    Report

    Report Number
    1220908-2013-01403
    Event Type
    Death
    Date Received
    June 5, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K112432
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT VIA ELECTRODE PADS, THE ASSOCIATED DEFIBRILLATOR DID NOT DISPLAY AN ECG SIGNAL. COMPLAINANT INDICATED THAT THE PATIENT EXPIRED PRIOR TO THE MEDICS ARRIVAL TO THE SCENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249729 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death