MEDFUSION
Received Apr 20, 2021
Report 3012307300-2021-03310 · MDR key 11695408
Product problems
- Device Alarm System
- Device Alarm System
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
INVESTIGATION COMPLETED ON A SMITHS MEDICAL SYRINGE INFUSION PUMPS/MEDFUSION 4000 PUMPS. THE REPORTED COMPLAINT OF TIME BASED BACK GROUND ERROR WAS NOT DUPLICATED WHEN POWERING THE DEVICE ON. HOWEVER, THE EVENT WAS DISCOVERED IN THE EVENT LOG. THE CAUSE WAS ISOLATED TO CUSTOMER DAMAGING MAIN BOARD DURING SUPER CAP. THE PHYSICAL CONDITION OF DEVICE REVEALED, TOP AND BOTTOM CASES ARE IN EXCELLENT CONDITION. COUNTERFEIT SUPER FOUND IN MAIN PC BOARD. NO VISIBLE CONTAMINATION. ACTION WAS TAKEN TO REPLACE THE MAIN BOARD.
Description of Event or Problem
INFORMATION RECEIVED A SMITHS MEDICAL SYRINGE INFUSION PUMPS/MEDFUSION 4000 PUMPS ALARMED TIME BASE BACKGROUND ERROR. NO ADVERSE PATIENT EVENTS WERE REPORTED.