BEUDAMED
    FDA Adverse Event Other Summary report: N

    KODAK DIRECTVIEW DR 7500 SYSTEM

    MDR report key: 1466315 · Received September 3, 2009

    Report

    Report Number
    1317307-2009-00002
    Event Type
    Other
    Date Received
    September 3, 2009
    Date of Event
    August 11, 2009
    Report Date
    September 3, 2009
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    KPR
    PMA / PMN Number
    K051258
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE "ALPHA" BUTTON IS ADJACENT TO THE "ALL" BUTTON ON THE OTC OPERATOR HANDLE. THE "ALL" BUTTON ALLOWS MANUAL OTC MOVEMENT IN LONGITUDINAL, TRANSVERSE AND VERTICAL DIRECTIONS. VERTICAL MOVEMENT (ONLY) IS ASSISTED AS NECESSARY BY A MOTOR INSIDE THE TELESCOPE ASSEMBLY. THE MOTOR IS SIGNALED TO ENGAGE AS FOLLOWS: THE OPERATOR PHYSICALLY INITIATES UP OR DOWN MOVEMENT WITH THE "ALL" BUTTON PRESSED. A TRANSDUCER INSIDE THE TELESCOPE ASSEMBLY SENSES THE VERTICAL DIRECTIONAL FLEX (UP OR DOWN) AND SENDS A SIGNAL THROUGH THE GAGE BOARD TO TURN ON THE MOTOR TO ASSIST THE VERTICAL MOVEMENT. FEEDBACK TO THE MOTOR THROUGH THE TRANSDUCER AND GAGE BOARD CONTINUE TO COMMUNICATE SIGNALS TO THE MOTOR TO SPEED UP, SLOW DOWN, OR DISENGAGE AS NEEDED. THE "ALPHA" BUTTON MENTIONED ABOVE ALLOWS MANUAL ANGULAR ROTATION OF THE OTC (OVERHEAD TUBE CRANE) IN THE ALPHA (WINDMILL) DIRECTION. PRESSING THIS BUTTON ALONE COULD NOT HAVE RESULTED IN THE MOTOR ASSISTED DOWNWARD MOVEMENT OF THE OTC THAT OCCURRED. THE MOTOR ASSIST IS ONLY ENGAGED WHEN OTC MOVEMENT IS ENABLED IN THE VERTICAL DIRECTION. INITIAL FAILURE ANALYSIS CONCLUDED THAT THE TRANSDUCER MALFUNCTIONED, INTERFERING WITH PROPER COMMUNICATION TO THE MOTOR. CORRECTIVE AND PREVENTIVE ACTIONS ARE BEING COORDINATED WITH THE OTC SUPPLIER.

    Description of Event or Problem · 1

    THE TECHNICIAN WAS POSITIONING THE OTC OVER A PT ON THE TABLE FOR A LATERAL EXAM. THE TECHNICIAN PRESSED THE "ALPHA" BUTTON, ALSO INADVERTENTLY PRESSING THE "ALL" BUTTON ON THE OTC OPERATOR HANDLE. THE OTC MOTOR DROVE THE OTC VERTICALLY DOWNWARD AT A HIGHER THAN USUAL RATE OF SPEED. THE OPERATOR DID NOT (OR POSSIBLY WAS UNABLE TO) RELEASE THE "ALL" BUTTON QUICKLY ENOUGH TO PREVENT PT CONTACT. THE OTC CONTACTED THE PT WITH SOME AMOUNT OF FORCE IN THE HIP AREA.

    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 48 YR