Vapor 19.3

Description of Event or Problem

It was reported that the extracorporal oxygenation of the patient was impaired during a surgical procedure which resulted in a hypoxia. The users reportely replaced the entire set-up of devices and accessories the patient was connected to, there wa sno detail in the report which would reasonably suggest that health consequences for the patient have occurred, finally. After checking the replaced devices, the users suspected that a malfunction of the Dräger anesthetic gas vaporizer might have restricted the gas/oxygen flow somehow before. The device has no UDI as a UDI was not required at the time the device was manufactured.

Additional Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up/final report.