BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 22814767 · Received August 15, 2025

    Report

    Report Number
    1220908-2025-03017
    Event Type
    Malfunction
    Date Received
    August 15, 2025
    Date of Event
    July 15, 2025
    Report Date
    August 4, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION. DURING THE INVESTIGATION IT WAS NOTED THAT DURING EVALUATION AT ZOLL UK WITH THE USER'S MULTI-FUNCTION CABLE (MFC), THE DEVICE WOULD NOT PROVIDE CPR FEEDBACK OR ENTER CPR MODE. THE MFC WAS FOUND TO BE FAULTY AND WAS REPLACED. THE BOTTOM PIN OF THE MFC LOW-VOLTAGE CONNECTOR WAS FOUND DAMAGED AND TOUCHING THE SIDE OF THE CONNECTOR. THE MFC WAS SCRAPPED AT ZOLL CHELMSFORD. THE DEVICE WAS RECERTIFIED FOR CLINICAL USE. NO TREND RELATED TO SIMILAR REPORTS.

    Additional Manufacturer Narrative · 0

    THIS DEVICE WAS MANUFACTURED BUT NOT DOMESTICALLY DISTRIBUTED; IT IS ONLY DISTRIBUTED IN THE INTENDED GEOGRAPHY. THERE IS NO EXISTING UDI REGULATION. 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 TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE POWERED UP IN THE INCORRECT MODE. 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
    1116181 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 630-2221111-05 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown