BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 8090778 · Received November 20, 2018

    Report

    Report Number
    1220908-2018-03404
    Event Type
    Death
    Date Received
    November 20, 2018
    Date of Event
    November 4, 2018
    Report Date
    November 5, 2018
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946004354
    PMA / PMN Number
    K112432/P160
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION. INSTEAD, THE CLINICAL DATA FILE WAS RETURNED. REVIEW OF THE CLINICAL DATA CONFIRMED THE REPORTED MALFUNCTION. THE DATA SHOWED THAT THE DEVICE WAS IN AN ECG LEAD FAULT STATE. ADDITIONAL INFORMATION "RECIEVED" FROM THE CUSTOMER "CONFIMRED" THAT THE ECG CABLE WAS PHYSICALLY DAMAGED. THE DEVICE REQUIRES AN ECG SIGNAL TO PERFORM ON DEMAND (SYNCHRONIZED) PACING. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRO CODE: DRO. ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) FEMALE PATIENT IN RESPIRATORY ARREST, THE DEVICE FAILED TO PACE AND WAS UNABLE TO OBTAIN AN ECG SIGNAL. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED; HOWEVER THEY DO NOT BELIEVE THIS WAS DEVICE ASSOCIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931432 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA 00847946004354

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death