BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E SERIES DEFIBRILLATOR

    MDR report key: 2031471 · Received March 18, 2011

    Report

    Report Number
    1220908-2011-00665
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K042007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE (B)(6) MALE PT WAS SCUBA DIVING AND SUBMERGED APPROXIMATELY 40 FEET WHEN HE SUFFERED AN EPISODE. WHEN HE WAS BROUGHT TO THE SURFACE, BYSTANDERS INITIATED CPR UNTIL THE FIRE DEPARTMENT ARRIVED. ONCE THEY ARRIVED, UPON PLACING ELECTRODES ON THE PT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E SERIES DEFIBRILLATOR E SERIES MKJ ZOLL MEDICAL CORPORATION E SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR