[18895]
Resident in wheelchair with lap belt fastened over lower abdomen. Nursing assistant started to push resident in wheelchair to dining room. Resident put feet down on floor and possible forward momentum and weight of resident caused the fastex sr-2 to unfasten and resident fell out of wheelchair landing on face on floor. Resident sustained tissues. Neurological checks were initiated. Another brand of lap belt was put on the wheelchair to prevent resident from falling/slipping out. On 8/8/95 wheelchair representative were in facility and noted that the female end of the fastex sr-2 buckle was broken. It is not known if the buckle was broken prior to or during the event. On 8/23/95 resident still has faint reddened area on left forehead. Device not labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Device not serviced in accordance with service schedule. No data - regarding date last serviced. Service provided by: invalid data. Service records not available. 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. Results of evaluation: component failure, telemetry failure, unanticipated adverse reaction - long term, component failure. Conclusion: device failure directly contributed to event. Certainty of device as cause of or contributor to event: no. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5