BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUINSA (MARKETED BY CARESTREAM)

    MDR report key: 1669061 · Received April 20, 2010

    Report

    Report Number
    1000404222-2009-00002
    Event Type
    Malfunction
    Date Received
    April 20, 2010
    Date of Event
    August 11, 2009
    Report Date
    September 9, 2009
    Manufacturer
    SUINSA
    Product Code
    IYB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE STRAIN GAUGE (WHEATSTONE BRIDGE THAT MEASURES OPERATOR EFFORT) SIGNAL WILL BE EVALUATED PRIOR TO VERTICAL SERVO MOTOR ASSISTANCE IS CONNECTED/ENABLED. STRAIN GAUGE SIGNAL WILL BE NOW MEASURED BY A NEW REVISION OF THE BOARD THAT MONITORS THE ACTIVATION/DEACTIVATION OF THE OTC (OVERHEAD TUBE CRANE) HANDLE BUTTONS. AT THE MOMENT THAT ANY DEAD MAN BUTTON THAT DEMANDS VERTICAL ASSISTED MOVEMENT IS ENABLED BY OPERATOR ("ALL" OR "VERTICAL") IF THE STRAIN GAUGE EFFORT READOUT IS NOT 0 (OR CLOSE TO, DUE TO TOLERANCE BAND) SUCH BOARD WILL IGNORE SUCH BUTTON DEMAND. THEREFORE IF STRAIN GAUGE MALFUNCTION OCCURS (LIKE INCIDENT DESCRIBED), WHENEVER OPERATOR TRIES TO MOVE OTC VERTICAL AXIS BY DEPRESSING BUTTON, THE NEW REVISION BOARD WILL DETECT A NON CLOSE TO 0 EFFORT AND THEREFORE SUCH BUTTON DEPRESS WILL BE COMPLETELY IGNORED AND THE MOTOR SERVO ASSISTANCE WILL NOT BE CONNECTED AT ALL.

    Description of Event or Problem · 1

    THE TECHNICIAN WAS POSITIONING THE OTC (OVERHEAD TUBE CRANE) 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 RELEASE THE "ALL" BUTTON QUICKLY ENOUGH TO PREVENT PT CONTACT. THE OTC CONTACTED THE PT WITH SOME AMOUNT OF FORCE IN THE HIP AREA. THE PT SAW A PHYSICIAN ON (B)(6) 2009. NO INJURY WAS DIAGNOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUINSA (MARKETED BY CARESTREAM) TUBE MOUNT, X-RAY, DIAGNOSTIC, IYB IYB SUINSA NOVA

    Patients

    Seq Age Sex Outcome Treatment
    1