[354]
10:13 p. M. , 8/124/92, resident found hanging over the side rail in a raised position with vest type restraint in place. Vest posey untied from bed and bed rails lowered to allow resident to be eased to the floor. No audible or visual respirations and no palpable pulse. Resident lifted to bed. Dusky in color,=. Cpr initiated with no response. Cpr stopped due to resident being determined to be a "no code blue" status. Skin cool, no apical pulse, nail beds blue. Dr. , police, and family notified. Deputy coroner present and investigation conducted. He reported to family in presence of director of nursing that he would rule her death accidental suffocation by restraint. "the strap of the vest was arround her mid-section and with all the weight, she couldn't breath". The resident had been observed approximately 30 minutes before the incident cwith no signs of problems, agitation or distressdevice 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. 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. Results of evaluation: patient's condition - predisposed event. Conclusion: device evaluated and alleged failure could not be duplicated. Certainty of device as cause of or contributor to event: yes. Corrective actions: device use continued with restrictions/limitations, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5