BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 858124 · Received May 25, 2007

    Report

    Report Number
    1220908-2007-01142
    Event Type
    Malfunction
    Date Received
    May 25, 2007
    Report Date
    May 16, 2007
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS CORP HAS REC'D THE PRODUCT AND WILL BE PROVIDING A F/U 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 DID NOT HAVE PACER OUTPUT. 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 CORPORATION MSERIES BI-PHASIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR