BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 6567745 · Received May 15, 2017

    Report

    Report Number
    1220908-2017-01090
    Event Type
    Malfunction
    Date Received
    May 15, 2017
    Date of Event
    April 6, 2017
    Report Date
    April 25, 2017
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    DRT
    PMA / PMN Number
    K112432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    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. REVIEW OF THE DEVICE HISTORY LOG PROVIDES EVIDENCE OF THE CUSTOMER'S REPORT, HOWEVER, THIS DOES NOT NECESSARILY INDICATE A DEVICE MALFUNCTION. THE DEVICE HISTORY LOG SHOWS SEVERAL "LEAD FAULT" ENTRIES. THIS MAY INDICATE POOR COUPLING BETWEEN THE ELECTRODE PADS AND THE PATIENT'S SKIN. THE ELECTRODES RETURNED WITH THE DEVICE WERE OBSERVED TO BE DRIED OUT, WHICH COULD CONTRIBUTE TO THE REPORTED MALFUNCTION. IT IS IMPORTANT TO NOTE THAT THIS MALFUNCTION OCCURRED IN LEADS MODE. THIS TYPE OF MALFUNCTION DOES NOT POSE ANY CLINICAL IMPACT AND DOES NOT MEET OUR GUIDELINES FOR REPORTABILITY. 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 (B)(6) FEMALE PATIENT DURING A FLIGHT TRANSPORT, 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
    348551 X SERIES DEFIBRILLATOR/PACEMAKER DRT ZOLL MEDICAL CORPORATION X SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR