Siemens became aware of an event that occurred while operating the artis pheno system.During an interventional procedure, the user reported unintentional system movements.The c-arm pilot swivel button was stuck, and the operator had to press the button for opposite direction to stop the c-arm movement.Siemens is unaware of any impact to the state of health of the patient involved.Siemens has requested additional information in order to conduct an investigation of the reported event.
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H3, h6: siemens healthcare completed the investigation of the reported event.As previously reported, siemens became aware of an event that occurred while operating the artis pheno system.During an interventional procedure, the user reported unintentional system movements.The clockwise swivel movement of the c-arm continued even though the operator removed their finger from the movement button.The movement was stopped by pressing the button that turns the c-arm in the opposite direction (counterclockwise).The procedure was then continued and finished on that system.To resolve the problem finally, the pilot module was exchanged as part of a service activity.The detailed investigation of the exchanged part showed that the button got stuck due to a tear of the button's soft membrane.The soft membrane was stuck between the switch and the cover, causing the movement to continue even after the button is no longer pressed.This is the first case where the button got stuck that an unintended swivel c-arm movement was performed.Collision prevention mechanisms such as the collision computer and collision sensors are in place for this kind of erroneous scenarios.Also, the movement can be stopped using the emergency button.The instruction for use gives adequate instructions.In this case, the movement was stopped by pressing the button that turns the c-arm counterclockwise.The occurrence rate of the aforementioned error pattern was checked.A possible error accumulation, which leads to a corrective action of the installed base, could not be determined by the investigation.No further actions are needed for this complaint.The complaint has been closed.
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