SUINSA (MARKETED BY CARESTREAM)

Description of Event or Problem

THE TECHNICIAN WAS POSITIONING THE OTC (OVERHEAD TUBE CRANE) OVER A PATIENT 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 PATIENT CONTACT. THE OTC CONTACTED THE PATIENT WITH SOME AMOUNT OF FORCE IN THE HIP AREA. THE PATIENT SAW A PHYSICIAN IN 2009. NO INJURY WAS DIAGNOSED.

Additional Manufacturer Narrative

THE STRAIN GAUGE 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.