Int.Ref.(b)(4).The digitaldiagnost system supports general radiographic imaging.For anatomies that are larger than the detector size, it is possible to make a series of exposures, covering the whole anatomy (for example full spine or full legs).These individual images can be "stitched" together via the software program.For proper patient positioning and support, the patient can be placed on the so called "patient support for stitching".For the ease of use, during transportation, the patient support for stitching has wheels and a folding footboard.The footboard is connected to the frame via two hinges and a brake cylinder.It has to be folded up and fixed by a hook for transportation, e.G.From one room to another.The brake cylinder has the task to ensure that the footboard lowers itself slowly (within 5-7 seconds) when the hook is released, to prevent the footboard from falling.If the operator steps on the footboard while it is still moving down, the mounting of the brake cylinder can break and the footboard fell down immediately.In a worst case, it may hit the foot of a person and break a bone.Philips field service engineer confirmed that the brake cylinder had broken out of the frame of the patient support for stitching.The cause for the issue is unknown.However the capa and fco investigation concluded that breaking of the cylinder can only result from abnormal use, so if the stand is used as intended there is no risk.Philips field service engineer replaced the whole patient support for stitiching and checked the system.System works as specified.A capa investigation was conducted with the result of acceptable risk per benefit risk determination.This issue is further monitored and trended.Correction: h6 result and conclusion code.
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