BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 21401505 · Received February 18, 2025

    Report

    Report Number
    1220908-2025-00447
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    January 24, 2025
    Report Date
    January 28, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946004354
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE, THE MULTIFUNCTION CABLE (MFC) AND MFC TO CPR-D ADAPTER WERE RETURNED TO ZOLL MEDICAL CORPORATION; THE DEVICE, THE MULTIFUNCTION CABLE (MFC) AND MFC TO CPR-D ADAPTER WERE PUT THROUGH EXTENSIVE TESTING INCLUDING CONTINUITY TESTING, WHICH CONFIRMED AN INTERMITTENT CONNECTION ON THE APEX SIDE OF THE MFC TO CPR-D ADAPTER, LEADING TO INCONSISTENT PAD DETECTION AND "OPEN/CONNECTED PADS" ISSUES THAT PREVENTED SHOCK DELIVERY. THE ADAPTER WAS REPLACED. THE DEVICE AND RETURNED MFC CABLE PASSED ALL FUNCTIONAL TESTS, INCLUDING DEFIB TESTS AND INTERNAL IMPEDANCE CHECKS, WITH NO DISCREPANCIES FOUND. THE MFC-TO-CPRD CONNECTOR WAS REPLACED TO RESOLVE THE REPORT. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. IT'S IMPORTANT TO MENTIION THAT THREE SHOCKS WERE DELIVERED IN THIS PATIENT EVENT LEADING UP TO THE REPORT TO THIS REPORT. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE 75 YEARS & GENDER MALE) THE DEVICE FAILED TO DELIVER A SHOCK. COMPLAINANT INDICATED THAT THE OPERATOR OBTAINED ANOTHER DEVICE AND SUCCESSFUILLY CONVERTED THE PATIENT. 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
    2669468 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 610-2231011-01 NA 00847946004354

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male