BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 17436370 · Received August 1, 2023

    Report

    Report Number
    1220908-2023-02989
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Date of Event
    July 11, 2023
    Report Date
    July 11, 2023
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CANADA; THE CUSTOMER'S REPORT WAS DUPLICATED AND ATTRIBUTED TO THE MULTIFUNCTION CABLE (MFC) AND MFC CONNECTOR. THE MFC CABLE AND MFC CONNECTOR WERE REPLACED TO REMEDY THE REPORT. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A 75-YEAR-OLD MALE PATIENT IN CARDIAC ARREST, THE DEVICE WAS UNABLE TO DETECT THE ATTACHED MULTIFUNCTION CABLE. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1697767 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male