MEDIREG II
Received May 2, 2024 · Event occurred Sep 11, 2023
Report 3003207908-2023-00001 · MDR key 19227583
Device
Generic name
Medireg Ii
Manufacturer
Gce, S.r.o.,Model number
0724114Catalog number
0724114
Lot number
0009638611
Product problems
- Improper or Incorrect Procedure or Method
- Improper or Incorrect Procedure or Method
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THERE IS AN INFORMATION THAT THE O-RING USED ON PRESSURE REGULATOR´S INLET CONNECTION IN TIME OF THE EVENT WAS FROM NBR WHICH IS MATERIAL NOT RECOMMENDED TO BE USED IN OXYGEN SERVICE.THE MEDIREG CONNECTION IS DAMAGED WITH A LEAK ACROSS THE O-RING DUE TO POOR MAINTENANCE THAT CONTRIBUTED TO IGNITION. THE MOST PROBABLE ROOT CAUSE OF IGNITION WAS INCORRECT USE - CONTRARY TO INFORMATION IN IFU; O-RING FROM NBR MATERIAL.
Description of Event or Problem
RIGIN DESRIPTION OF THE INCIDENT: DATE: (B)(6) 2023 LOCATION: (B)(5). INCIDENT DESCRIPTION: "PATIENT COMPLAINED THAT HIS REGULATOR WAS "SMOKING". HE MENTIONED THAT FOLLOWING THE IGNITION HE EVEN REPLACED OR ADDED ANOTHER O RING THE INCIDENT WAS KNOWN TO US AT A LATER STAGE. PATIENT CONTINUED TO USE THE REGULATOR FOLLOWING "IGNITION INCIDENT". REGULATOR ALSO SHOWS MARKS OF DAMAGE DUE TO DROP OUTCOME: NO INJURIES. "