BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 2081738 · Received April 12, 2011

    Report

    Report Number
    1220908-2011-00937
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K990762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED MALFUNCTION WAS OBSERVED DURING TESTING. HOWEVER, THE REPORTED PROBLEM COULD NOT BE DUPLICATED. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING, WHICH INCLUDED ENVIRONMENTAL AND FUNCTIONAL TESTING WITHOUT DUPLICATING THE MALFUNCTION. A SYSTEM INTERCONNECT CABLE WAS REPLACED AS A PRECAUTION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO PACE A (B)(6), MALE, PT, THE DEVICE'S PACER OUTPUT WAS NOT ADJUSTABLE. COMPLAINANT INDICATED THAT THE CLINICIAN 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.

    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 55 YR