BEUDAMED
    FDA Adverse Event Death Summary report: N

    AED10

    MDR report key: 1670309 · Received April 26, 2010

    Report

    Report Number
    3023750-2010-01089
    Event Type
    Death
    Date Received
    April 26, 2010
    Date of Event
    April 17, 2010
    Report Date
    April 21, 2010
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RECEIVED FOR EVALUATION, AND A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE TREATING A PT IN CARDIAC ARREST, THE DEVICE SUCCESSFULLY DELIVERED ONE DISCHARGE OF ENERGY; HOWEVER, ON THE SECOND ATTEMPT TO DELIVER ENERGY, THE DEVICE WAS UNABLE TO DISCHARGE. COMPLAINANT INDICATED THAT THE CLINICIANS PERFORMED CPR AND OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PT. COMPLAINANT INDICATED THAT THE PT 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