BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 20866762 · Received December 6, 2024

    Report

    Report Number
    1220908-2024-04465
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    November 21, 2024
    Report Date
    November 22, 2024
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER'S REPORT WAS OBSERVED DURING REVIEW OF THE DEVICE LOGS. THE LOGS INDICATE THE DEVICE SHUT DOWN DUE TO A LOW BATTERY. THE LOG ALSO SUGGESTS THE BATTERY REQUIRED CALIBRATION AND THE DEVICE WAS INTERMITTENTLY COMMUNICATING TO THE BATTERY FOR USER ADVISORIES. THE X SERIES OPERATOR'S GUIDE (PN: 9650-002355-01) (REV: G) INFORMS THE USER, "FOR BEST PERFORMANCE OF THE BATTERY, YOU SHOULD RECALIBRATE THE BATTERY AS SOON AS POSSIBLE" AFTER SEEING THAT CALIBRATION IS REQUIRED. THE DEVICE AND RETURNED BATTERY WERE PUT THROUGH EXTENSIVE FUNCTIONAL TESTING WITHOUT DUPLICATING THE REPORT. THE BATTERY COMMUNICATION ASSEMBLY AND BATTERY WERE REPLACED AS A PRECAUTION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 0

    JUSTIFICATION FOR NO UDI: 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.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE INAPPROPRIATELY SHUTDOWN. 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
    2516983 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 620-2231511-21 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown