ADU
Received Jan 26, 2018 · Event occurred Dec 29, 2017
Report 9610105-2018-00004 · MDR key 7222031
Device
Product problems
- Leak/Splash
- Leak/Splash
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
NO REPORT OF PATIENT INVOLVEMENT. THE CUSTOMER BIOMEDICAL ENGINEER TROUBLESHOT THE SYSTEM WITH GE HEALTHCARE TECHNICAL SUPPORT. THE ABSORBER CARTRIDGE WAS REPLACED TO RESOLVE THE REPORTED ISSUE.
Description of Event or Problem
THE HOSPITAL REPORTED THAT THE UNIT SHOWS HIGH LEAKAGE WHEN THEY RUN THE START UP TEST. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE LEAK WAS CAUSED BY THE COMPACT BLOCK ABSORBER CANISTER WHICH IS NOT A GE PRODUCT, BUT A CAREFUSION PRODUCT. THERE WAS NO MALFUNCTION OF THE GE HEALTHCARE EQUIPMENT SO THIS EVENT IS NOT REPORTABLE.