BEUDAMED
    FDA Adverse Event Death Summary report: N

    AED10

    MDR report key: 1530701 · Received November 11, 2009

    Report

    Report Number
    3023750-2009-01163
    Event Type
    Death
    Date Received
    November 11, 2009
    Date of Event
    August 1, 2008
    Report Date
    October 29, 2009
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT, THE DEVICE FAILED TO DISCHARGE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AED10 AUTOMATED EXTERNAL DEFIB MKJ WELCH ALLYN PROTOCOL, INC. AED10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death