BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED

    MDR report key: 1191465 · Received September 24, 2008

    Report

    Report Number
    3023750-2008-00223
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 26, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K021168
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BUT ADDITIONAL TIME IS REQUIRED TO COMPLETE THE INVESTIGATION. UPON THE COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE DEVICE IS ONLY SHOCKING AT 360 JOULES DURING TESTING. NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AED MKJ WELCH ALLYN PROTOCOL, INC. AED 10

    Patients

    Seq Age Sex Outcome Treatment
    1