BEUDAMED
    FDA Adverse Event Death Summary report: N

    AED 20

    MDR report key: 1831249 · Received September 3, 2010

    Report

    Report Number
    3023750-2010-01190
    Event Type
    Death
    Date Received
    September 3, 2010
    Date of Event
    July 22, 2010
    Report Date
    August 25, 2010
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED, AND A F/U REPORT WILL BE PROVIDED WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A FEMALE PT WHO WAS IN CARDIAC ARREST, THE DEVICE WAS UNABLE TO OBTAIN ECG SIGNAL AND FAILED TO DETECT SHOCKABLE RHYTHMS DUE TO EXCESSIVE MOTION/ARTIFACT. COMPLAINANT INDICATED THAT THE CLINICIAN 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 AED 20 AUTOMATED EXTERNAL DEFIB MKJ WELCH ALLYN PROTOCOL, INC. AED20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death