BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODEMASTER XL+

    MDR report key: 1972974 · Received January 20, 2011

    Report

    Report Number
    1218950-2011-00188
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Report Date
    November 16, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    LDD
    PMA / PMN Number
    K954957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE FAILED ITS ROUTINE MAINTENANCE TESTS. THE DEVICE WAS FOUND TO NOT DELIVER THE SELECTED ENERGY. NO REPAIR WAS PERFORMED SINCE THE DEVICE IS OUT OF SUPPORT. THE CAUSE WAS NOT DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED ITS ROUTINE MAINTENANCE TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODEMASTER XL+ LDD, MKJ, DQA LDD PHILIPS HEALTHCARE M1722B

    Patients

    Seq Age Sex Outcome Treatment
    1