[19253196]
During an anesthetic, the tubing came loose from the airway pressure monitor. This resulted in a sudden, large leak in the anesthesia circuit which made it difficult to adequately ventillate the patient. The problem was corrected before any injury to the patient occurred. The tubing fitting is inadequate to securely fasten the tubing to the fitting. This was reported to the distributor (ohmeda) after a previous incident. Their suggested repair, a tubing clamp. Was placed and did not prevent this incidentdevice 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-oct-92. Service provided by: factory trained/authorized/owned service organization. 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, mechanical tests performed, performance tests performed, visual examination. Results of evaluation: design - inadequate, telemetry failure, none or unknown, connector or adaptor. Conclusion: device failure occurred and was related to event, device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service, use of all similar devices stopped permanently. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5