BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 5739862 · Received June 21, 2016

    Report

    Report Number
    1220908-2016-01488
    Event Type
    Malfunction
    Date Received
    June 21, 2016
    Report Date
    June 1, 2016
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    DRT
    PMA / PMN Number
    K112432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE REPORTED MALFUNCTION WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING WITHOUT DUPLICATING THE MALFUNCTION. THE DEVICE HISTORY LOG SHOWS EVIDENCE OF A CONNECTIVITY ISSUE BETWEEN THE ELECTRODE PADS AND THE PATIENT, HOWEVER, THIS DOES NOT NECESSARILY INDICATE A DEVICE MALFUNCTION. THE EVENT ELECTRODES WERE NOT RETURNED TO ZOLL FOR EVALUATION AS PART OF THIS INVESTIGATION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. 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 WAS UNABLE TO OBTAIN AN ECG SIGNAL. 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
    391923 X SERIES DEFIBRILLATOR/PACEMAKER DRT ZOLL MEDICAL CORPORATION X SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1