BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 5471383 · Received March 1, 2016

    Report

    Report Number
    1220908-2016-00450
    Event Type
    Death
    Date Received
    March 1, 2016
    Report Date
    February 11, 2016
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K112432
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION AND AFTER EXTENSIVE TESTING, THE REPORTED MALFUNCTION WAS UNABLE TO BE DUPLICATED. REVIEW OF THE DEVICE HISTORY LOGS DID NOT PROVIDE EVIDENCE OF THE CUSTOMER'S REPORT. AN ECG SIGNAL WAS CAPTURED THROUGHOUT THE CASE AND WE CAN SEE THE ECG VIEW BEING CHANGED VIA THE FRONT PANEL BUTTON, HOWEVER, ECG IS PRESENT. THIS INVESTIGATION HAS BEEN CLOSED AS DEVICE MEETS SPECIFICATION. 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 PRODUCT AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) FEMALE PATIENT IN CARDIAC ARREST, THE DEVICE DISCHARGED SUCCESSFULLY ONE TIME TO THE PATIENT THEN LOST ECG SIGNAL. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127989 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death