BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E SERIES DEFIBRILLATOR

    MDR report key: 5995068 · Received October 3, 2016

    Report

    Report Number
    1220908-2016-02361
    Event Type
    Malfunction
    Date Received
    October 3, 2016
    Report Date
    September 13, 2016
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K042007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS CONTACTED FOR RETURN OF THE SUSPECT PRODUCT. THE CUSTOMER HAS RESPONDED AND INDICATED THE PRODUCT WILL NOT BE RETURNING TO ZOLL.

    Additional Manufacturer Narrative · 1

    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 DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE INAPPROPRIATELY SHUT OFF. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION. COMPLAINANT INDICATED THAT DURING SUBSEQUENT BIOMED TESTING, THE MALFUNCTION WAS NOT DUPLICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645089 E SERIES DEFIBRILLATOR E SERIES MKJ ZOLL MEDICAL CORPORATION E SERIES N/A

    Patients

    Seq Age Sex Outcome Treatment
    1