The following information was provided by the state via e-mail:
During an inspection on March 17 through 19, 2009, the ODH [Ohio Department of Health] inspector identified through the licensee's radiation safety committee meeting minutes an incident involving the Co-60 Gamma Knife that occurred on December 15, 2008, at approximately 2:15 pm. During a patient treatment, the couch moved out of treatment position. The emergency stop button was activated and the system did not respond. The licensee's staff had to manually pull out the couch from the Gamma Knife and manually close the doors to the Gamma Knife to shield the source.
According to the licensee, radiation exposure to all individuals involved with the incident was minimal. The incident DID NOT result in a medical event for the patient. The manufacturer (Elekta) was immediately contacted and the Gamma Knife was repaired. Patient treatment was resumed and completed without incident. According to Elekta, the Gamma Knife system experienced an illegal couch sensor error due to a known software bug problem.
The licensee failed to notify the Ohio Department of Health, Bureau of Radiation Protection of this device failure and therefore this is determined to be non-compliant with the provisions of rule 3701:1-40-20 (B)(2)(a,b,c) of the Ohio Administrative Code.
Ohio State Reference Number: OH 2009-008