BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 7489832 · Received May 7, 2018

    Report

    Report Number
    1220908-2018-01234
    Event Type
    Malfunction
    Date Received
    May 7, 2018
    Report Date
    April 16, 2018
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946004354
    PMA / PMN Number
    K112432/P160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION; A ZOLL REPRESENTATIVE WENT ON SITE AND THE MALFUNCTION WAS DUPLICATED AND THE LI-ON BATTERY WAS REPLACED TO REMEDY THE PROBLEM. THE CUSTOMER'S BATTERY WAS DISCARDED ON SITE. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION; A ZOLL REPRESENTATIVE WENT ON SITE AND EVALUATED THE DEVICE. THE REPORTED MALFUNCTION WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS PUT THROUGH A PREVENTIVE MAINTENANCE CHECK WITHOUT DUPLICATING THE REPORTED MALFUNCTION. THE DEVICE WAS RECERTIFIED AND PUT BACK INTO SERVICE. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE RESTART/REBOOT ITSELF. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT 1220908-2018-01245 FOR A SIMILAR EVENT REPORTED FROM THE SAME CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334607 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA 00847946004354

    Patients

    Seq Age Sex Outcome Treatment
    1