BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODEMASTER XL

    MDR report key: 2121279 · Received May 4, 2011

    Report

    Report Number
    1218950-2011-01271
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Report Date
    April 14, 2011
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    LDD
    PMA / PMN Number
    K954957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE UNIT FAILED TO POWER UP. THE CUSTOMER WAS INFORMED THAT THIS DEVICE HAS BEEN OUT OF SUPPORT SINCE DECEMBER 2006 AND PARTS ARE NO LONGER AVAILABLE. BASED ON THE CUSTOMERS' REPORT, WE WILL CONSIDER THIS A REPORTABLE MALFUNCTION OF THE UNIT. WE CANNOT DETERMINE THE CAUSE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE UNIT FAILED TO POWER UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODEMASTER XL LDD,MKJ,DQA LDD AGILENT TECHNOLOGIES, INC. M1723B

    Patients

    Seq Age Sex Outcome Treatment
    1