BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 20556210 · Received October 29, 2024

    Report

    Report Number
    1220908-2024-03900
    Event Type
    Malfunction
    Date Received
    October 29, 2024
    Date of Event
    October 8, 2024
    Report Date
    October 8, 2024
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946004354
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER'S REPORT OF WAS OBSERVED DURING REVIEW OF THE DEVICE DATA LOGS. HOWEVER, THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING INCLUDING BENCH HANDLING AND STRESS TESTING WITHOUT DUPLICATING THE REPORT. THE MULTIFUNCTION CABLE AND CPRD ADAPTER WERE REPLACED AS A PRECAUTION. THE CUSTOMERS' REPORT OF UNABLE TO DISCHARGE WAS NOT REPLICATED OR CONFIRMED. THE DEVICE AND THE RETURNED ACCESSORIES WERE PUT THROUGH EXTENSIVE TESTING WITHOUT DUPLICATING THE REPORT. REVIEW OF THE ACTIVITY LOG SHOWED THE USER WAS ABLE TO SUCCESSFULLY DELIVER A 120J SHOCK (ENERGY DELIVERED: 149.5J, PATIENT IMPEDANCE: 255 OHMS, PATIENT TTI: 88.4 OHMS) AT 10:02:34. THE DEVICE ALSO PASSED MULTIPLE 30J TESTS LATER IN THE DAY. IT'S UNCLEAR WHAT LED THE USER TO BELIEVE THAT NO SHOCK WAS DELIVERED DESPITE THE DEVICE SAYING ENERGY WAS DELIVERED, HOWEVER, IT IS IMPORTANT TO NOTE THAT PATIENT MOVEMENT IS NOT A RELIABLE INDICATOR OF ENERGY BEING DELIVERED. 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 DEFIBRILLATE A 58-YEAR-OLD FEMALE PATIENT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS AND FAILED TO DISCHARGE. 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
    924629 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 610-2231011-01 NA 00847946004354

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female