BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 1981870 · Received January 13, 2011

    Report

    Report Number
    1220908-2010-03853
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Report Date
    December 28, 2010
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K990762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PT, AFTER 3 SHOCKS ON THE FOURTH ATTEMPTED CHARGE, THE DEVICE DISPLAYED A "BRIDGE TEST FAILED" MESSAGE. COMPLAINANT INDICATED THAT THE CLINIC OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION. COMPLAINANT INDICATED THAT THE ELECTRODE PADS INVOLVED IN THE REPORTED MALFUNCTION WERE NOT RETAINED BY THE CUSTOMER.

    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 UNK