[107]
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 questionable burns. It was noted that the clear plactic covering had slipped down the wires and exposed the face to the soldering joint. Patient was seen by his physician on the morning of december 3, 1991. The physician noticed at this time three burns. The burns wre questionable 1st, 2nd and 3rd degree burns. The physician perscribed bacitracin ointment to the affected areas and saw the patient agin on december 5, 1991. No new treatment was perscribed. The multi-sleep study was sucessful. A bio-medical engineer checked the thermioster box. It worked according to the manufacturer's specification. The thermioster was removed from service. The manufacturer was immediately contacted by respiratory therapydevice 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. Results of evaluation: design, electrical problem. Conclusion: invalid data. Certainty of device as cause of or contributor to event: yes. Corrective actions: user education provided, invalid data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5