Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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Based on the provided information and tests performed on site there is no indication of a malfunction of the mr system, coil or gamma knife positioning frame used.This and similar incidents have been thoroughly investigated by a joint philips and elekta team, in cooperation with the local clinical radiation therapy team of the guiyang site.Amongst others, a site visit has been conducted together with elekta to observe the sites workflow, the logfiles of incidents were reviewed, the system was tested and a similar elekta frame was tested in best.Main results: patient injuries do not correlate with high rf dose examinations.There is no apparent placement of any parts of the frame at the location of the injuries.In a clinical setting 'no temperature rise' was observed, using a temperature scanner, hat can explain any skin reaction on the forehead.It is concluded that the reported injuries are not related to the mr system nor the elekta gamma knife positioning frame.It is suspected that the injuries are caused by specific local actions.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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