[923]
This personal body holder was applied to a 81 year old female patient in our institution who was somewhat confused. The device was applied in the appropriate and recommended manner. The patient was checked on a regulr basis. Forty-five minutes after one night-time check the patient was found to have slid down in the bed, slipped between the split siderails on the side of the bed, and her had her head tangled in the restraint device cutting off her ability to breathe. The patient was blue and unresponsive when found. The restraint device was quickly cut and removed from her and the patient was resuscitated. While her life was sustained, she was transferred to intensive care unit on a ventilator. It was determined that the patient's brain function had been significantly affected and she was unable to trigger respirations on her own. Per a decision of the family the patient ws removed from the ventilator and died that same dayinvalid data - regarding single use labeling of device. Patient medical status prior to event: fair condition. Invalid data - regarding 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. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: yes. Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5