BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODEMASTER XL+

    MDR report key: 1961453 · Received January 10, 2011

    Report

    Report Number
    1218950-2011-00086
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Report Date
    December 13, 2010
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    LDD
    PMA / PMN Number
    K954957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT CHARGE OVER 50J. WE ARE CONSIDERING THIS A MALFUNCTION BASED ON THE CUSTOMER REPORT. THIS PRODUCT HAS BEEN OUT OF SUPPORT SINCE (B)(4) 2006. PHILIPS INFORMED THE CUSTOMER THAT THIS UNIT IS OUT OF SUPPORT. THE LACK OF AVAILABILITY OF REPLACEMENT PARTS MEANS THAT PHILIPS/CUSTOMER WILL BE UNABLE TO DETERMINE CONCLUSIVELY WHICH, IF ANY, ASSEMBLY FAILED. NO FURTHER INVESTIGATION IS POSSIBLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT CHARGE OVER 50J.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODEMASTER XL+ LDD,MKJ,DQA LDD AGILENT TECHNOLOGIES, INC. M1722B

    Patients

    Seq Age Sex Outcome Treatment
    1