BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCR COMPANO

    MDR report key: 2690127 · Received July 16, 2008

    Report

    Report Number
    3003768251-2008-00007
    Event Type
    Malfunction
    Date Received
    July 16, 2008
    Date of Event
    January 25, 2008
    Report Date
    January 28, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS GMBH DMC, DEVELOPMENT AND
    Product Code
    LLZ
    PMA / PMN Number
    K963980
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION - THE ROOT CAUSE OF THIS PROBLEM IS A SOFTWARE RELATED ISSUE. A FIELD CHANGE ORDER WILL BE RELEASED TO CORRECT THIS SOFTWARE ISSUE.

    Description of Event or Problem · 1

    THIS X-RAY SYSTEM WILL INTERMITTENTLY EXPORT FLIPPED IMAGES TO THE PICTURE ARCHIVING COMPUTER SYSTEM (PACS). THESE FLIPPED IMAGES REFERS TO IMAGE INVERSION AND CAN BE DESCRIBED AS ¿MIRRORED¿ WHERE THE LEFT AND RIGHT ARE REVERSED. INVERTED WOULD APPLY TO THE TOP AND BOTTOM BEING REVERSED. THE RANDOM CHANGES IN THE IMAGE ORIENTATION COULD HAVE BEEN ANY OF THE FOUR POSSIBLE ORIENTATION ERRORS. A REBOOT OF THE SYSTEM WILL TEMPORARILY RESTORE NORMAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCR COMPANO LLZ (PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM) LLZ PHILIPS MEDICAL SYSTEMS GMBH DMC, DEVELOPMENT AND 732028 NA

    Patients

    Seq Age Sex Outcome Treatment
    1