[19548789]
On 8/27/92, 67 year old female of basal cell gangliconic degenerative syndrome was found with her head through the side rails while bed was at an approximate 20 degree angle. She had been checked minutes before by rn while doing rounds, then when the brother of resident came in found her in the above explained situation. There was emotional trauma to resident which was relieved with care and comfort from rn but no physical side effects. We tested siderails and found an average size head can fit easily if at a specific angle through side rails up to shoulders. The everest & jennings co. Was called and stated that after twenty years of producing these siderails, it has become known to them that in the past year this type of incident is possible. They sent us a fish net type cover that adheres to the siderails to prevent the head from going through the siderails bars. This still does have to be put on and off each time the siderails are put down, as it does not collapse with the siderail. Also it does not pad the siderail for bruising that can happen if head is put through; it does stop head from going through siderail past crown of head. We ordered a pair of siderails that was designed for this problem, but they have not had available one to fit our beds properly. If this works well we plan to order a supply to use on residents sythat are targeted as a potential for this problem. Until that time, we are using padded velcro fitted siderail pads that fit inside rail for the safety of residentsdevice not 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. 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 - inadequate. Conclusion: device was out of spec in a manner that relates to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device use continued with restrictions/limitations. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5