[2297]
On december 3, 1991, multi-channel sleep study was completed. The nasal thermioster was removed. Upon removal, it was noted patient's facial cheek had two small questionnable burns. Nasal thermioster which measures flow for the multi-channel sleep study has a clear plastic protective covering over the soldering joint to the cannula. It was noted that the clear plastic covering had slipped down the wires and exposed the face to the soldering joint. Patient was seen by his physician on the moring of december 3, 1991. The physician noted at this time three burns. The burns were questionnable 1st, 2nd, and 3rd degree burns. The physician ordered bacitracin ointment to the affected areas. The physician saw the patient again on december 5, 1991. No new treatment was prescribed. The physician will see the patient again in two weeks. Device not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-dec-91. Service provided by: other. 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, performance tests performed. Results of evaluation: manufacturing. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5