BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 6772078 · Received August 7, 2017

    Report

    Report Number
    1220908-2017-01861
    Event Type
    Malfunction
    Date Received
    August 7, 2017
    Report Date
    July 21, 2017
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946004170
    PMA / PMN Number
    K990762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PROCODE = DRO. THE REPORTED MALFUNCTIONS WERE OBSERVED AND ATTRIBUTED TO A SYSTEM INTERCONNECT FLEX CABLE THAT WAS NOT PROPERLY SEATED. THE CABLE WAS RESEATED TO CORRECT THE REPORTED PROBLEM. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE DEVICE DISPLAYED "DEFIB FAULT 72" AND "PACER FAULT 116" MESSAGES. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552120 M SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION MSERIES BI-PHASIC NA 00847946004170

    Patients

    Seq Age Sex Outcome Treatment
    1