BEUDAMED
    FDA Adverse Event Death Summary report: N

    AED10

    MDR report key: 1276692 · Received December 31, 2008

    Report

    Report Number
    3023750-2008-00322
    Event Type
    Death
    Date Received
    December 31, 2008
    Date of Event
    November 28, 2008
    Report Date
    December 4, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K021168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE UNIT FAILED WHILE IN USE. SYSTEM FAILURE POPPED UP ON THE SCREEN AND THE UNIT WOULD NOT SHOCK OR FOLLOW THE PROTOCOL. THE USER THEN EMPLOYED ANOTHER DEFIBRILLATOR ON THE PATIENT. THE PATIENT EXPIRED, BUT THE USER DID NOT KNOW WHETHER THE REPORTED FAILURE CONTRIBUTED TO THE OUTCOME. THE REPORTER DID NOT KNOW THE PATIENT IDENTIFIER, ALTHOUGH HE SAID THAT IT WAS CONNECTED TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AED10 MKJ WELCH ALLYN PROTOCOL, INC. AED 10

    Patients

    Seq Age Sex Outcome Treatment
    1 Death