BEUDAMED
    FDA Adverse Event Summary report: N

    M SERIES

    MDR report key: 1941359 · Received December 20, 2010

    Report

    Report Number
    1220908-2010-03600
    Date Received
    December 20, 2010
    Report Date
    November 29, 2010
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    MKJ
    PMA / PMN Number
    K011865
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP 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 DISPLAY FLICKERS AND WAS NOT READABLE. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORP. MSERIES CCT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA