BEUDAMED
    FDA Adverse Event Death Summary report: N

    AED PLUS

    MDR report key: 6121025 · Received November 22, 2016

    Report

    Report Number
    1220908-2016-02874
    Event Type
    Death
    Date Received
    November 22, 2016
    Date of Event
    October 30, 2016
    Report Date
    November 2, 2016
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K011541
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION AND THE DEVICE'S MAIN BOARD WAS REPLACED TO RESOLVE THE MALFUNCTION. IT IS IMPORTANT TO NOTE THAT THE MALFUNCTION WAS PRESENT BEFORE THE END USER USED THE DEVICE DURING THE REPORTED EVENT. REVIEW OF THE DEVICE HISTORY LOGS INDICATE THAT THE DEVICE FAILED A MONTHLY TEST PRIOR TO THE INCIDENT AND WAS IN A RED X STATE. THE DEVICE OPERATED AS DESIGNED WITHIN THE LIMITATIONS OF TECHNOLOGY AVAILABLE BY ALERTING THE END USER THAT THE DEVICE WAS NOT READY FOR USE. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    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 AN (B)(6) YEAR OLD MALE PATIENT , THE DEVICE WOULD NOT POWER UP. 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
    773063 AED PLUS DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION AED PLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death