BEUDAMED
    FDA Adverse Event Death Summary report: N

    AED 20

    MDR report key: 1770101 · Received July 20, 2010

    Report

    Report Number
    3023750-2010-01138
    Event Type
    Death
    Date Received
    July 20, 2010
    Date of Event
    May 5, 2010
    Report Date
    July 9, 2010
    Manufacturer
    WELCH ALLYN PROTOCOL, INC
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR EVAL, AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B) (6) MALE PT FOR CARDIAC ARREST, THE DEVICE FAILED TO DISCHARGE. COMPLAINANT INDICATED THAT THE PT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AED 20 AUTOMATED EXTERNAL DEFIB MKJ WELCH ALLYN PROTOCOL, INC AED20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death