BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 1964855 · Received December 23, 2010

    Report

    Report Number
    1220908-2010-03625
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Report Date
    December 2, 2010
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K990762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ZOLL AND VISUAL EVAL OF THE DEVICE FOUND EVIDENCE THAT THE CUSTOMER HAD DISASSEMBLED THE DEVICE IN AN ATTEMPT TO REPAIR THE DEVICE DUE TO THE CONDITION IN WHICH THE DEVICE WAS RECEIVED, ROOT CAUSE ANALYSIS COULD NOT BE PERFORMED. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "DEFIB FAULT 85" MESSAGE. 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