BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KODAK DIRECTVIEW DR 7500 SYSTEM

    MDR report key: 1706767 · Received May 25, 2010

    Report

    Report Number
    1317307-2010-00001
    Event Type
    Malfunction
    Date Received
    May 25, 2010
    Date of Event
    May 4, 2010
    Report Date
    May 25, 2010
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    KPR
    PMA / PMN Number
    K051258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE ANALYSIS CONFIRMED THAT THE STRAIN GAUGE (TRANSDUCER) FAILED IN THE "OPEN" POSITION - THIS BLOCKED ANY FEEDBACK THAT WOULD SIGNAL THE OTC MOTOR TO SLOW DOWN OR STOP. THE STRAIN GAUGE/TRANSDUCER AND GAUGE BOARD HAVE BEEN REPLACED AS A REPAIR FOR THE FAILURE MODE. IN ADDITION, BECAUSE A RE-DESIGN OF THE CONSOLE INTERFACE BOARD OR BUTTON BOARD WILL IMPROVE THE PERFORMANCE OR QUALITY OF THE DEVICE, SERVICE WILL INSTALL A CONSOLE INTERFACE BOARD OR BUTTON BOARD. THE PROBABILITY OF OCCURRENCE FOR A POTENTIAL ADVERSE OUTCOME IS IMPROBABLE, OR VERY UNLIKELY TO OCCUR BASED UPON 500 DR UNITS X 60,000 ESTIMATED EXAMS/YEAR, 5 FAILURES (PAST 12 MONTHS) / 30,000,000 EXAMS/YEAR = 1.67X10-7.

    Description of Event or Problem · 1

    THE OPERATOR COMPLETED AN X-RAY EXPOSURE AND PRESSED THE "ALL OR OMNI" BUTTON TO MOVE THE OTC TO THE END OF THE X-RAY TABLE. THE PT WAS LYING IN A LATERAL POSITION ON THE TABLE. THE OPERATOR THEN PRESSED THE OTC VERTICAL BUTTON TO RAISE THE OTC UP, HOWEVER, THE OTC MOVED VERTICALLY DOWNWARD. THE OPERATOR RELEASED THE OTC VERTICAL BUTTON, AND THE OTC MOVEMENT STOPPED, WITHOUT CONTACTING THE PT. THE OPERATOR COMPLAINT OF ARM PAIN, HOWEVER, NO INJURY WAS REPORTED TO CARESTREAM HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KODAK DIRECTVIEW DR 7500 SYSTEM DR 7500 KPR CARESTREAM HEALTH, INC. DR 7500

    Patients

    Seq Age Sex Outcome Treatment
    1