[21247850]
Resident disoriented in bed attempted to get out of bed fell to floor after rail collasped to floor. Resident was taken to the e. R. Suffered laceration left forehead, possible concussion, severe bruising both eyes, swollen left shoulder. Bolt on bed has threaded end no locking nut cotter pin or retainer, were on the other rail bolts on the bed. Unknown if lock nuts are routinely on these bolts. Bolt that bed rail pivots down on, was found lying in floor. This type rail has 2 large bolts at foot and head of bed, rail lock is released and rail lowers about one inch below the level of the mattress. Without the bolt the rail drops to the floor. This event removes any support that a user may have while leaning on the rail to get out of bed. Invalid data - regarding single use labeling of device. Patient medical status prior to event: satisfactory 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, mechanical tests performed, visual examination. Results of evaluation: design, design - inadequate, manufacturing, mechanical problem. Conclusion: invalid data. Certainty of device as cause of or contributor to event: yes. Corrective actions: device temporarily removed from service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5