BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 8828390 · Received July 25, 2019

    Report

    Report Number
    1220908-2019-02099
    Event Type
    Death
    Date Received
    July 25, 2019
    Date of Event
    June 24, 2019
    Report Date
    July 15, 2019
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    DRT
    PMA / PMN Number
    K112432/P160
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY ZOLL MEDICAL CORPORATION. THE REPORTED MALFUNCTION WAS NOT DUPLICATED OR CONFIRMED. THE DEVICE WAS SUBJECTED TO EXTENSIVE TROUBLESHOOTING WHICH INCLUDED BENCH HANDLING, STRESS TESTING THROUGH PADS WITHOUT ANY DISCREPANCIES. REVIEW OF DEVICE'S ACTIVITY LOGS INDICATES THAT IN THE REPORTED EVENT DATE THE DEVICE DID RECOGNIZE THE ATTACHED PADS BUT THE DEVICE WAS IN LEADS VIEW. LOGS INDICATE THAT THE PADS LEAD VIEW WAS NOT SELECTED DURING THE CASE WHICH IS NECESSARY TO VIEW ECG SIGNAL VIA PADS. THIS CLAIM HAS BEEN CLOSED AS USER ERROR. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE DEVICE AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN) IN CARDIAC ARREST, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620620 X SERIES DEFIBRILLATOR/PACEMAKER DRT ZOLL MEDICAL CORPORATION X SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death