MalfunctionCAN
MEDISELECT II
Received May 2, 2024 · Event occurred Sep 2, 2021
Report 3003207908-2021-00001 · MDR key 19227490
Device
Generic name
Mediselect Ii
Manufacturer
Gce, S.r.o.,Model number
0720124Catalog number
0720124
Lot number
9024359
Product problems
- Misassembly by Users
- Misassembly by Users
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ORIGINAL DESCRIPTION OF EVENT IN (B)(6) HOSPITAL (B)(6) GERMANY: A EMPLOYEE CONNECTED AN OXYGEN PRESSURE REDUCTION VALVE TO A 3L CYLINDER. THE REDUCTION VALVE GOT HOT DURING OPENING THE CYLINDER VALVE. THAN THE EMPLOYEE CLOSED THE VALVE AND BURNED HIS HAND. THE EMPLOYEE AFFIRMED THAT HE HAD NOT USED ANY DISINFECTANTS OR HAND CREAM.
Additional Manufacturer Narrative
THE MOST POSSIBLE CAUSE OF IGNITION: INSUFFICIENT TIGHTENING OF THE INLET NUT ON THE CYLINDER VALVE.