BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODEMASTER XE

    MDR report key: 2222426 · Received July 14, 2011

    Report

    Report Number
    1218950-2011-02003
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Report Date
    June 22, 2011
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    LDD
    PMA / PMN Number
    K954957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE DELIVERED 120 JOULES INSTEAD OF THE SELECTED 100 JOULES. THERE WAS NO REPORT OF PT INVOLVEMENT. THE CUSTOMER WAS INFORMED THAT THIS DEVICE HAS BEEN OUT OF SUPPORT SINCE DECEMBER 2005 AND PARTS ARE NO LONGER AVAILABLE. BASED ON THE CUSTOMERS' REPORT, WE WILL CONSIDER THIS A MALFUNCTION. WE CANNOT DETERMINE THE CAUSE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE DELIVERED 120 JOULES INSTEAD OF THE SELECTED 100 JOULES. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODEMASTER XE LDD, MKJ, DQA LDD AGILENT TECHNOLOGIES, INC. M1724A

    Patients

    Seq Age Sex Outcome Treatment
    1