BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 21336802 · Received February 7, 2025

    Report

    Report Number
    1220908-2025-00502
    Event Type
    Malfunction
    Date Received
    February 7, 2025
    Date of Event
    January 8, 2025
    Report Date
    January 24, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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 PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE DEVICE PERFORMED TO SPECIFICATION. THE LOGS WERE REVIEWED FOR THE REPORTED EVENT DATE AND SHOWED CHARGE ATTEMPTS WHERE THE DEVICE WAS FULLY CHARGED AFTER EIGHT SECONDS AND THEN 20 SECONDS. ALL CHARGES WERE WITHIN THE 25 SECOND SPECIFICATION FOR A DEVICE OPERATING ON BATTERY POWER AS SPECIFIED BY THE OPERATOR'S GUIDE (93650-002355-01, REV: G). 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 TOOK AN EXTENDED TIME TO CHARGE TO 150J. 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
    867044 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 610-2231011-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown