BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 8128450 · Received November 29, 2018

    Report

    Report Number
    1220908-2018-03470
    Event Type
    Malfunction
    Date Received
    November 29, 2018
    Report Date
    November 8, 2018
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    DRO
    UDI-DI
    00847946018269
    PMA / PMN Number
    K112432/P160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION; THE REPORTED MALFUNCTION WAS OBSERVED AND ATTRIBUTED TO A SYSTEM INTERCONNECT FLEX CABLE THAT WAS NOT PROPERLY SEATED. A SYSTEM INTERCONNECT FLEX CABLE WAS REPLACED TO REMEDY THE PROBLEM. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE FAILED SELF-TEST FOR PACER FUNCTION. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958179 X SERIES DEFIBRILLATOR/PACEMAKER DRO ZOLL MEDICAL CORPORATION X SERIES NA 00847946018269

    Patients

    Seq Age Sex Outcome Treatment
    1