BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 1650832 · Received March 26, 2010

    Report

    Report Number
    1220908-2010-00630
    Event Type
    Malfunction
    Date Received
    March 26, 2010
    Report Date
    March 8, 2010
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO A THIRD PARTY, THE BRIDGE BOARD WAS REPLACED. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. THE BRIDGE BOARD WAS RETURNED TO ZOLL MEDICAL CORP, UNITED STATES. TESTING OF THE BOARD WAS NOT ABLE TO DUPLICATE THE MALFUNCTION. THE CUSTOMER CONFIRMED THAT REPLACING THE BRIDGE BOARD RESOLVED THE MALFUNCTION. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "DEFIB FAULT 78" MESSAGE. ZOLL MEDICAL CORP HAS NOT RECEIVED THE DEVICE FOR EVAL, AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    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