BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 2110243 · Received May 20, 2011

    Report

    Report Number
    1220908-2011-01404
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Report Date
    May 3, 2011
    Manufacturer
    ZOLL MED CORP.
    Product Code
    MKJ
    PMA / PMN Number
    K060559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MED CORPORATION 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 DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE'S DEFIB OUTPUT WAS OUT OF SPEC. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER MKJ ZOLL MED CORP. R SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA