BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 18677006 · Received February 9, 2024

    Report

    Report Number
    1220908-2024-00423
    Event Type
    Malfunction
    Date Received
    February 9, 2024
    Date of Event
    December 24, 2023
    Report Date
    January 19, 2024
    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

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

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CANADA FOR EVALUATION. THE CUSTOMER'S REPORT WAS OBSERVED DURING REVIEW OF THE DEVICE DATA LOGS. HOWEVER, THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING INCLUDING DEFIB/PACER STRESS TESTING, BENCH HANDLING, AND DEFIB CYCLING, USING THE RETURNED MULTIFUNCTION (MFC) CABLE AND MFC RECEPTACLE, WITHOUT DUPLICATING THE REPORT. AN INTERNAL INSPECTION FOUND NO DISCREPANCIES. THE MFC RECEPTACLE AND MFC CABLE WERE REPLACED AS A PRE-CAUTION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "CABLE FAULT" MESSAGE WHICH DELAYED DEFIBRILLATION. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242425 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown