BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODEMASTER XL

    MDR report key: 2082707 · Received April 28, 2011

    Report

    Report Number
    1218950-2011-01209
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Report Date
    April 5, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    LDD
    PMA / PMN Number
    K954957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS STILL BEING INVESTIGATED. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO POWER UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODEMASTER XL LDD, MKJ, DQA LDD PHILIPS HEALTHCARE M1723B

    Patients

    Seq Age Sex Outcome Treatment
    1