MalfunctionMRZ

MEDFUSION

Received Apr 8, 2021

Report 3012307300-2021-02973 · MDR key 11636926

Device

Generic name

Syringe Pump

Manufacturer

St Paul

Model number

3500

Catalog number

3500-0600-01

Product problems

Device Alarm System
Power Problem
Device Alarm System
Power Problem

Patient

Not reported

Insufficient Information
Insufficient Information

Narrative

Additional Manufacturer Narrative

INVESTIGATION COMPLETED ON A SMITHS MEDICAL SYRINGE INFUSION PUMPS/MEDFUSION 3500 PUMPS . THE COMPLAINT OF WILL NOT BOOT UP COMPLETELY AND LIGHTS UP WHEN ALARMING WAS CONFIRMED. EVENT LOG REVEALED ERROR ALARM. WHEN POWERING UP DEVICE IT REVEALED A BLACK GREEN SCREEN AND ALARMED. THIS WAS ISOLATED TO THE MAIN BOARD WHICH WAS REPLACED.

Description of Event or Problem

INFORMATION RECEIVED A SMITHS MEDICAL SYRINGE INFUSION PUMPS/MEDFUSION 3500 PUMPS WOULD NOT BOOT UP COMPLETELY AND LIGHTS UP THEN STARTS TO ALARM. NO PATIENT INJURY REPORTED