[4779]
On 8/6/93 at 1330, resident was sitting up in a w/c with a lap tray in place, when resident fell to floor. Resident suffered a 2 inch linear laceration on right forehead, bleeding from right nostril and a non-displaced fracture at base of left thumb. To be followed by an orthopedist. After all, it was noted that the velcro straps attached to the lap tray had come loose. After determination that the lap tray had been properly applied; closer inspection of lap tray revealed washers missing form screws securing the velcro strap which had come loose. The strap came off the screws, causing loosening of the whole lap tray, and subsequently led to residents fall. All lap trays of this type were immediately removed from use. Device 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, visual examination. Results of evaluation: material degradation/deterioration. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: use of all similar devices stopped permanently. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5