[16263293]
Client was admitted the afternoon of january 16th. He was aware of admission and answered questions appropriately during the day. In the evening and during the night of january 17th, client was somewhat confused, (even by his how statement). During the early morning hours of jan. 17th client scooted down to the foot end of the bed, somehow he got his legs caught in the side rails. The siderail fell on his right leg and he sustained a long (27-29 cm) excoriation of the shin. This was cleansed and dressed with tegaderm. The dressing is changed daily. In the morning, i was told the siderail did not stay up during the night shift. When the side rail was checked by maintenance, they found the knob turned sideways, straightenefd it and the side rails works well and hold fastdevice labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, performance tests performed, visual examination. Results of evaluation: design - human factors, mechanical problem, patient's condition - predisposed event. Conclusion: device failure occurred and was related to event, device failure related to patient condition, device evaluated and alleged failure could not be duplicated, user error contributed to event. Certainty of device as cause of or contributor to event: maybe. Corrective actions: device repaired and put back in service, device temporarily removed from service, user education provided. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5