BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 8855818 · Received August 2, 2019

    Report

    Report Number
    1220908-2019-02254
    Event Type
    Death
    Date Received
    August 2, 2019
    Date of Event
    July 20, 2019
    Report Date
    July 24, 2019
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    DRT
    UDI-DI
    00847946006372
    PMA / PMN Number
    K112432/P160
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION; THE MALFUNCTION WAS DUPLICATED AND ATTRIBUTED TO A FAULTY MFC-TO-CPRD CONNECTOR. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. THE CUSTOMER RECEIVED A REPLACEMENT MFC-TO-CPRD CONNECTOR. 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.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT IN CARDIAC ARREST (AGE & GENDER UNKNOWN),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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648853 X SERIES DEFIBRILLATOR/PACEMAKER DRT ZOLL MEDICAL CORPORATION X SERIES NA 00847946006372

    Patients

    Seq Age Sex Outcome Treatment
    1 Death