BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIC

    MDR report key: 837681 · Received April 10, 2007

    Report

    Report Number
    3023750-2007-00077
    Event Type
    Death
    Date Received
    April 10, 2007
    Date of Event
    March 15, 2007
    Report Date
    March 16, 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
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND ADDITIONAL TIME IS REQUIRED TO COMPLETE THE INVESTIGATION. UPON DEVICE RECEIPT AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE UNIT FAILED TO DELIVER ENERGY AS SET. THE FIRST SHOCK SET AT 200 JOULES DELIVERED AT 180, THE SECOND SHOCK SET AT 200 JOULES DELIVERED 29. THIRD SHOCK AT 360 JOULES DELIVERED 165. THE PT DID CONVERT BRIEFLY AFTER THE FIRST SHOCK BUT DID NOT SURVIVE. PID RUN 3158 ON THE DATE OF THE EVENT.

    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 44 YR Death