BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 6880663 · Received September 20, 2017

    Report

    Report Number
    1220908-2017-02369
    Event Type
    Death
    Date Received
    September 20, 2017
    Date of Event
    August 25, 2017
    Report Date
    August 30, 2017
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    DRT
    UDI-DI
    00847946004378
    PMA / PMN Number
    K112432
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE DEVICE PERFORMED TO SPECIFICATION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. REVIEW OF THE CLINICAL DATA DID SHOW THAT THERE WAS A GOOD CONNECTION BETWEEN THE DEVICE AND THE ELECTRODE PADS. ALTHOUGH THERE WAS NO ECG SIGNAL ON THE DISPLAY, THIS IS NOT AN INDICATION OF A DEVICE MALFUNCTION. THE DEVICE WAS IN THE INCORRECT VIEW MAKING IT APPEAR AS THOUGH THERE WAS NO ECG SIGNAL. THE USER WOULD NEED TO SWITCH TO THE "PADS" VIEW TO OBTAIN THE ECG SIGNAL VIA THE ELECTRODE PADS ATTACHED TO THE PATIENT. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO CARDIOVERT AN (B)(6) YEAR OLD MALE PATIENT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED, HOWEVER IT WAS NOT A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660829 X SERIES DEFIBRILLATOR/PACEMAKER DRT ZOLL MEDICAL CORPORATION X SERIES NA 00847946004378

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death