MalfunctionBSZ
ADU
Received Sep 7, 2016 · Event occurred Aug 8, 2016
Report 9610105-2016-00043 · MDR key 5932567
Device
Product problems
- Leak/Splash
- Leak/Splash
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE DISPOSABLE SODA LIME WAS REPLACED AND PATIENT CIRCUIT WAS RESEATED TO FIX THE REPORTED ISSUE. NO REPORT OF PATIENT INVOLVEMENT.
Description of Event or Problem
THE HOSPITAL REPORTED THAT, THE UNIT FAILED THE LEAK TEST. THERE WAS NO REPORTED PATIENT INVOLVEMENT.