BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIA DISTRIBUTION CENTER

    MDR report key: 2315446 · Received October 6, 2011

    Report

    Report Number
    3007584706-2011-00001
    Event Type
    Malfunction
    Date Received
    October 6, 2011
    Report Date
    July 29, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS TECHNOLOGIES, LTD.
    Product Code
    LLZ
    PMA / PMN Number
    K072960
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHILIPS HAS DETERMINED THAT, UNDER CERTAIN CIRCUMSTANCES, WHEN MORE THAN ONE DICOM PRINTER IS CONFIGURED, IT IS POSSIBLE TO SELECT AND USE A DICOM PRINTER WITH AN INCORRECT PRINT PROFILE TO PERFORM TRUE-SIZE PRINTING. IF THE CALIBRATION DATA IN THE PRINT PROFILE DOES NOT CORRESPOND TO THE PRINTER, MEASUREMENTS MADE ON TRUE-SIZE PRINTOUTS MAY THEREFORE BE INACCURATE, WHICH MAY RESULT IN MISDIAGNOSIS. NO PATIENT HARM WAS REPORTED. THE PROBLEM WAS FOUND AT THE MANUFACTURER'S FACILITY DURING SOFTWARE VERIFICATION, AND FOLLOWING ADDITIONAL TESTS, THE SAME ISSUE WAS FOUND IN A RELEASED SW VERSION. THIS PROBLEM WAS NOT FOUND IN THE FIELD AND NO SIMILAR ISSUES HAVE BEEN REPORTED BY USERS. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION REGARDING THIS ISSUE AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    PHILIPS HAS DETERMINED THAT UNDER CERTAIN CIRCUMSTANCES, WHEN MORE THAN ONE DICOM PRINTER IS CONFIGURED, IT IS POSSIBLE TO SELECT AND USE A DICOM PRINTER WITH AN INCORRECT PRINT PROFILE TO PERFORM TRUE-SIZE PRINTING. THERE HAS BEEN NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDIA DISTRIBUTION CENTER LLZ PHILIPS MEDICAL SYSTEMS TECHNOLOGIES, LTD. 830044

    Patients

    Seq Age Sex Outcome Treatment
    1