LEVEL 1 NORMO FLO IRRIGATION FAST FLOW SYSTEM
Received Jun 19, 2019
Report 3012307300-2019-03620 · MDR key 8714378
Device
Generic name
Warmer, Irrigation Solution
Manufacturer
Smiths Medical Asd, IncModel number
CON-H-1129Catalog number
CON-H-1129
Product problems
- Infusion or Flow Problem
- Infusion or Flow Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE LEVEL 1 NORMOFLO IRRIGATION FAST FLOW SYSTEMS HAD NO CIRCULATION. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.
Additional Manufacturer Narrative
DEVICE EVALUATION : ONE LEVEL ONE DEVICE WAS RECEIVED FOR INVESTIGATION IN POOR CONDITION WITH PRESSURE CUFFS. POWERED ON DEVICE AND IT DID NOT CIRCULATE. NEXT, THE BACK PANEL WAS REMOVED FOR FURTHER INVESTIGATION. ALL COMPONENTS WERE VISUALLY INSPECTED AND NO DAMAGE WAS FOUND. THE DEVICE POWERED ON AS INTENDED. THE MEASURED TEMPERATURE AT 41.7 DEGREES WAS ALSO FOUND TO BE WITHIN TOLERANCE. HOWEVER, A FAULTY PCB WAS FOUND AFTER USING ANOTHER TEST PCB ON THE UNIT. ADDITIONAL ISSUES WERE ALSO FOUND: THE ACTUATOR POLE AND TWO CASTER WHEELS WERE BENT, THE TOP REGULATOR WAS BROKEN, AND THE UNIT FAN GUARD WAS MISSING. BASED ON THE INVESTIGATION, THE COMPLAINT WAS CONFIRMED. NO PROBLEM SOURCE COULD BE IDENTIFIED.