BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIC

    MDR report key: 834587 · Received April 2, 2007

    Report

    Report Number
    3023750-2007-00070
    Event Type
    Death
    Date Received
    April 2, 2007
    Date of Event
    March 7, 2007
    Report Date
    March 7, 2007
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K012766
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN REC'D AND REQUIRES ADDITIONAL TIME TO COMPLETE THE ANALYSIS. A SUPPLEMENTAL WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE UNIT WOULD NOT DO THE SECOND SHOCK, PT WAS IN CARDIAC ARREST AND DIED. FIRE/RESCUE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIC MKJ MKJ WELCH ALLYN PROTOCOL, INC. PIC 50 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death