BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AED

    MDR report key: 807459 · Received January 17, 2007

    Report

    Report Number
    3023750-2006-00170
    Event Type
    Injury
    Date Received
    January 17, 2007
    Date of Event
    March 1, 2005
    Report Date
    December 19, 2006
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    k002232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS UNIT FAILED DURING RESUSCITATION. THE BATTERY WAS CHANGED BUT NO EFFECT. THE SCREEN WAS BLANK. NOTE 1 RE A1: PT IDENTIFIER NOT YET RECEIVED. WE DO NOT EXPECT TO RECEIVE IT, GIVEN THE TIME ELAPSED SINCE THE DATE OF THE EVENT. NOTE RE B2: NO PT INJURY. UNK WHETHER A REPLACEMENT UNIT WAS AVAILABLE. NOTE RE B3: THE DATE OF THE EVENT WAS REPORTED TO BE IN 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AED MKJ MKJ WELCH ALLYN PROTOCOL, INC. AED20 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *