BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 2953910 · Received January 14, 2013

    Report

    Report Number
    1220908-2013-00024
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Report Date
    January 3, 2013
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K060559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE THE DEVICE WAS UNABLE TO SWITCH OUT OF PACER MODE. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20254 R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION R SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA