MalfunctionCAN
MEDIREG II
Received Jun 10, 2026 · Event occurred Jan 31, 2026
Report 3003207908-2026-00002 · MDR key 25456763
Device
Product problems
- No Apparent Adverse Event
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE PRODUCTION HISTORY HAS BEEN CHECKED. GCE REQUESTED THE PHYSICAL INVOLVED DEVICE FOR INVESTIGATION IN GCE ACCREDITED LAB.
Description of Event or Problem
ORIGIN DESCRIPTION IN CUSTOMER´S LETTER, DATED (B)(6) 2026: "IN (B)(6) 2026, AN INCIDENT OCCURRED AT A CUSTOMER SITE IN ESTONIA INVOLVING A MEDIREG II 02 SS REGULATOR USED IN CONNECTION WITH AN OXYGEN CYLINDER. DURING USE, HEAT AND A LOCALIZED FIRE WERE OBSERVED AT THE CONNECTION POINT BETWEEN THE REGULATOR AND THE CYLINDER VALVE. THE SITUATION WAS PROMPTLY CONTAINED, THE DEVICE WAS TAKEN OUT OF SERVICE, AND NO INJURIES WERE REPORTED.".