BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIC40

    MDR report key: 1618895 · Received February 24, 2010

    Report

    Report Number
    3023750-2010-01034
    Event Type
    Death
    Date Received
    February 24, 2010
    Report Date
    February 9, 2010
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    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 TREAT A PATIENT, THE DEVICE FAILED TO DISCHARGE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED. COMPLAINANT INDICATED THAT SUBSEQUENT TESTING DID NOT DUPLICATE THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIC40 AUTOMATED EXTERNAL DEFIB MKJ WELCH ALLYN PROTOCOL, INC. PIC40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death