MalfunctionMRZ
MEDFUSION
Received Apr 23, 2021 · Event occurred Mar 24, 2021
Report 3012307300-2021-03393 · MDR key 11712741
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 SMITHS MEDICAL SYRINGE INFUSION PUMPS/MEDFUSION 4000 PUMPS. THE COMPLAINT OF PRIMARY AUDIBLE ALARM BGND TEST WAS UNABLE TO BE DUPLICATED IN OCCLUSION TESTING, HOWEVER THIS WAS REVEALED IN THE EVENT LOG. ACTION WAS TAKEN TO REPLACE THE SPEAKER AS PREVENTION. DEVICE PASSED ALL TESTING AND WAS IN OVERALL GOOD PHYSICAL CONDITION.
Description of Event or Problem
INFORMATION RECEIVED A SMITHS MEDICAL SYRINGE INFUSION PUMPS/MEDFUSION 4000 PUMPS ALARMED "PRIMARY AUDIBLE BACKGROUND TEST ALARM." THERE WAS NOT PATIENT INVOLVEMENT AS EVENT OCCURRED DURING TESTING.