BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIGITAL DIAGNOST VM

    MDR report key: 964598 · Received December 12, 2007

    Report

    Report Number
    1217116-2007-00047
    Event Type
    Other
    Date Received
    December 12, 2007
    Date of Event
    November 7, 2007
    Report Date
    November 14, 2007
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    KPR
    PMA / PMN Number
    K982795
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION - (OTHER) - THE INCORRECT USE OF THE MANUAL STITCHING CAUSED THIS EVENT. THE CAUSE FOR INCORRECT MANUAL STITCHING WAS FIRST DUE TO THE STITCHED (COMPOSITE) IMAGE WAS USED FOR DIAGNOSTIC WITHOUT CAREFULLY CHECKING THE OVERLAP AREA. SECOND, THE STITCHING WAS MADE ACCORDING TO THE RULER INSTEAD OF THE ANATOMY. THE INSTRUCTION FOR USE CLEARLY DESCRIBES THE STITCHING MECHANISM AND POINTS OUT ITS POSSIBLE "LIMITATIONS". THE SYSTEM IS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    SCOLIOSIS STITCHING STUDY WAS PERFORMED ON THE PT. THE STITCHED IMAGE WAS PRESENTED WITH NO FAILURE INDICATED. THE SPINE APPEARED FRACTURED. THE RULER DID NOT APPEAR COMPLETELY IN THE IMAGE. ON THE RAW PRE-SHOTS, THE DOTS OF THE RULER CAN BE SEEN, BUT NOT THE WHOLE RULER. THE STITCHED IMAGE DOES NOT SHOW THE DOTS ON THE LOWER IMAGE. PT WAS BACK BOARDED AND SENT TO LOCAL HOSP FOR MRI AND FOLLOW-UP X-RAYS. THE SPINE WAS NOT FRACTURED AS INDICATED IN THE STITCHING STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIGITAL DIAGNOST VM KPR (STATIONAY DIAGNOSTIC X-RAY SYSTEM) KPR PHILIPS MEDICAL SYSTEMS 712050 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other