BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODEMASTER XL

    MDR report key: 3252572 · Received July 15, 2013

    Report

    Report Number
    1218950-2013-03052
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Report Date
    June 18, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LDD
    PMA / PMN Number
    K954957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHILIPS TO ORDER A POWER SUPPLY REPLACEMENT. THE REPLACEMENT OF A POWER SUPPLY COULD INDICATE A POSSIBLE MALFUNCTION OF THE DEVICE. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328024 CODEMASTER XL LDD, MKJ, DQA LDD PHILIPS MEDICAL SYSTEMS M1723B

    Patients

    Seq Age Sex Outcome Treatment
    1