MalfunctionMRZ
MEDFUSION
Received May 14, 2021
Report 3012307300-2021-04373 · MDR key 11829090
Product problems
- Device Alarm System
- Device Alarm System
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION COMPLETED ON A SMITHS MEDICAL SYRINGE INFUSION PUMPS/MEDFUSION 4000 PUMPS COMPLAIN OF BASE HARDWOOD FAILURE WAS REVEALED IN THE EVENT HISOTRY LOG AND CONFIMRED DURING POWERING THE DEVICE UP. THE CAUSE IS MULTIPLE CONPONANTS OF INTERCONNECT BOARD AND BATTERY. ACTION WAS TAKEN TO REPLACE THE INTERCONNECT BOARD AND BATTERY.
Description of Event or Problem
INFORMATION RECEIVED A SMITHS MEDICAL SYRINGE INFUSION PUMPS/MEDFUSION 4000 PUMPS ALARMED BASE HARDWARE FAILURE. NO PATIENT ADVERSE EVENTS REPORTED.