[813]
Chair check by bed-check corp. 1. Ordered unit 1/23/92 for fennichia. 2. Unit arrived 2/6/92. Fennichia's balance much better. Units are inappropriate for her use. 3. 2/11/92 - installed unit on weikel's chair according to instructions, which shows it on sling seat wheelchair. Unit functioned well 2/11 days and evening shifts. 4. 2/12/92. Unit did not go off xl when patient left chair. O. T. Checked battery and sensory pad- all intact. Pt called bed check corp. And told greg honifen in engineering of malfunction. He said sometimes pad crease causes malfunction. Sensor pad was not creased. Greg air shipped a new unit and a new sensor pad to dsh physical therapy department. O. T. Informed staff not to rely on unit as sole means of alerting them to patient's exiting chair. On 2/13/92 unit malfunctioned at least three times. From 2/25/92 to 2/26/92 unit continues to malfunction (alarm system)device not labeled for single use. 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, a device from same lot was evaluated, mechanical tests performed. Results of evaluation: component failure, alarm failure. Conclusion: device failure directly contributed to event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5