BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES DEFIBRILALTOR

    MDR report key: 2120079 · Received May 26, 2011

    Report

    Report Number
    1220908-2011-01474
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Report Date
    May 10, 2011
    Manufacturer
    ZOLL MEDICAL CORP
    Product Code
    MKJ
    PMA / PMN Number
    K060559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WOULD NOT POWER UP ON BATTERY POWER. ONCE AC POWER WAS APPLIED THE DEVICE'S DISPLAY SHOWED HORIZONTAL LINES AND WAS NOT LEGIBLE. 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 DEFIBRILALTOR DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORP R SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA