BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 3124032 · Received May 15, 2013

    Report

    Report Number
    1220908-2013-01200
    Event Type
    Injury
    Date Received
    May 15, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K060559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS REC'D 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 A (B)(6), FEMALE PT WAS BEING DEFIBRILLATED USING THIS DEVICE DURING OPEN HEART SURGERY. THE PT REC'D SECOND DEGREE BURNS FROM THE ASSOCIATED DEFIB ELECTRODE PADS. COMPLAINANT DID NOT INDICATE THAT THERE WAS FURTHER ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214883 R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION R SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other