BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 2192624 · Received July 1, 2011

    Report

    Report Number
    1220908-2011-01823
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Report Date
    June 9, 2011
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K990762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS CONTACTED FOR RETURN OF THE DEVICE. THE CUSTOMER INDICATED THAT THE DEVICE WILL NOT BE RETURNED TO ZOLL FOR EVALUATION. THE CUSTOMER CONFIRMED THAT RESETTING A FLEX CABLE RESOLVED THE MALFUNCTION AND THE DEVICE WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE'S PACER OUTPUT CONTINUED TO RESET TO ZERO. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT 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