Tube mount, x-ray, diagnostic

Additional Manufacturer Narrative

(B)(6) (INITIAL REPORTER) SENT INFORMATION OF THE INCIDENT TO THE (B)(6), OFFICIAL CORRESPONDENT FOR SYFM (US, MANUFACTURER). THE WARRANTY AGREEMENT FOR THE UNIT ENDED ON (B)(6) 2012 AND HAS NOT SINCE BEEN SERVICED BY (B)(6). ON THE DAY OF THE ADVERSE EVENT, THE CLINIC CALLED (B)(6) TECHNICAL SUPPORT TO REPORT THE INCIDENT. THE FIELD SERVICE ENGINEER ((B)(6), TECHNICAL SUPPORT FOR (B)(6)) WAS DISPATCHED TO THE FACILITY AND VERIFIED THAT THE X-RAY TUBE WAS CALIBRATED TO STOP 12 INCHES ABOVE THE TABLE. HE DID NOT IDENTIFY ANY ISSUES AND CONFIRMED THE SYSTEM WAS FUNCTIONING PROPERLY. HE REPORTED THAT THE XRAY SYSTEM IS STILL IN USE AT THE CLINIC.

Description of Event or Problem

AS REPORTED BY THE CLINIC AT WHICH THE INCIDENT OCCURRED, PATIENT WAS LYING SUPINE ON A TABLE TO HAVE IMAGING PERFORMED, A LEFT AXILLARY VIEW SHOULDER. THE MOTORIZED X-RAY TUBE WAS COMMANDED TO DRIVE DOWN VERTICALLY BY THE RADIOLOGY TECHNOLOGIST. THE TECHNOLOGIST CEASED PUSHING THE BUTTON BUT THE X-RAY TUBE CONTINUED TO DRIVE DOWN. THE X-RAY TUBE IMPACTED THE PATIENT'S LEFT KNEE AND LOCKED. THE TECHNOLOGIST DID NOT USE THE EMERGENCY STOP BUTTON AND DID NOT LOWER THE TABLE TO FREE THE PATIENT. THE PATIENT'S KNEE WAS REMOVED FROM BETWEEN THE TABLE AND THE X-RAY TUBE. THE PATIENT RECEIVED FIRST AID CARE IMMEDIATELY. THE PATIENT WAS ABLE TO AMBULATE TO THEIR CAR FOLLOWING THE INCIDENT. THE CLINIC WAS CONTACTED ON EIGHT OCCASIONS AND DECLINED TO SHARE INFORMATION ABOUT THE CURRENT STATUS OF THE PATIENT.