[15031132]
A 79 year old female patient was transported to endoscopy at 0726 march 7, 1994 for a bronchoscopy. During the procedure the physician intubated the patient using the bronchoscope and a endotracheal tube. The bronchoscope was removed and a swivel oxygen adapter was connected the taped. The white membrane of the adapter remained in place. The bronchoscope was then reinserted. Oxygen saturation decreased to 84%, and the physician gave orders to increase the oxygen flow rate to 15 1/min. Approximately 30-60 seconds later, facial edema, adbominal distension, and neck distension were noted. The physician extubated the patient, positioned her on the right side and mantained the airway. A code was called. The patient was reintubated and cardiopulmonary resuscitation was in progress. A chest x-ray was taken which indicated bilateral pneumothoraces. A right and left chest tube were inserted and cardiopulmonary resuscitation continued. However, the patient did not respond to aggressive medical treatment and expired at 0836. (please reference 450056-1994-002 and 450056-1994-008there was only one death but multiple devices used. )device labeled for single use. Patient medical status prior to event: invalid data. 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: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: no. Corrective actions: invalid data. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5