|
Model Number AAS00161-20 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Low Oxygen Saturation (2477)
|
Event Date 11/28/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
The device was not returned for evaluation.A review of the appropriate device history records of the superdimension console indicates this device was released meeting all quality specifications.Out of an abundance of caution, superdimension is filing this mdr due to the additional risk associated with multiple exposures to general anesthesia.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, intra-operatively, they were unable to start the enb procedure due to the patient's lung volume levels while under anesthesia.The patient was put under general anesthesia and was retaining co2.Patient's lung volume prior was in the 500s and when the scope was introduced to begin the procedure, the patient¿s lung volume levels dropped significantly to the upper 50s.Due to safety concerns, the physicians decided to not proceed and cancelled the procedure.The patient was under general anesthesia.The patient's lung physiology was not compatible with anesthesia.The patient fully recovered.
|
|
Search Alerts/Recalls
|
|
|