MalfunctionMRZ
MEDFUSION
Received May 14, 2021
Report 3012307300-2021-04369 · MDR key 11828622
Product problems
- Device Alarm System
- Device Alarm System
Patient
Not reported
- Endocarditis
- Endocarditis
Narrative
Additional Manufacturer Narrative
INVESTIGATION COMPLETED ON A SMITHS MEDICAL SYRINGE INFUSION PUMPS/MEDFUSION 4000 PUMPS COMPLAINT OF BACK UP ALARM WAS NOT CONFIRMED DURING TESTING, HOWEVER IT WAS REVEALED IN THE EVENT LOG. THE CAUSE WAS UNKOWN AS THE BLUE TOKIN SUPER CAP PRESENT ON THE MAIN PC BOARD. ACTION WAS TAKEN AS PREVENTATIVE GOAL AND MAIN PC BOARD WAS REPLACED. DEVICE WAS IN OVER ALL GOOD CONDITION. DEVICE PASSED ALL FUNCTIONAL TESTING.
Description of Event or Problem
INFORMATION RECEIVED A SMITHS MEDICAL SYRINGE INFUSION PUMPS/MEDFUSION 4000 PUMPS MALFUNCTIONED AS DISPLAYED BACK UP AUDIBLE ALARM. NO PATIENT ADVERSE EVENTS REPORTED.