[3386]
The side rail on the patient rail had been previously reported as being impaired by the nursing staff, in that it would not remain in the raised position. The nursing staff had the rail in raised position on the day of the incident. The patient was found on the floor by the bed with the rail down. The patient had paralysis in extremeties since a cva several years ago, so was unable to lower rail. The maintenance staff had inspected and tested the rail by pulling pushing force to get the rail to fall down and it would not. The patient had a fractured humerous and arm was placed in an immoblizer. The latch and rail was felt to have possibly been worn and both were replaceddevice not labeled for single use. Patient medical status prior to event: invalid data. 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, mechanical tests performed, performance tests performed, visual examination. Results of evaluation: expected wear/deterioration, material degradation/deterioration. Conclusion: device failure indirectly caused event, device evaluated and alleged failure could not be duplicated, no failure detected and product within specification. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5