BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 4841899 · Received June 8, 2015

    Report

    Report Number
    1220908-2015-01457
    Event Type
    Malfunction
    Date Received
    June 8, 2015
    Report Date
    May 19, 2015
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946007065
    PMA / PMN Number
    K972241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION, THE MALFUNCTION WAS DUPLICATED AND ATTRIBUTED TO THE LITHIUM BATTERY ON THE SYSTEM BOARD. THE DEVICE OPERATOR'S GUIDE INSTRUCTS USERS TO REPLACE THE LITHIUM BATTERY ON THE DEVICE EVERY 5 YEARS. THIS DEVICE IS APPROXIMATELY 13 YEARS OLD. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WAS INTERMITTENTLY UNABLE TO POWER ON. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369793 M SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION MSERIES NA 00847946007065

    Patients

    Seq Age Sex Outcome Treatment
    1 NA