inforMED
MalfunctionCAN

C

Received Nov 27, 2024 · Event occurred Oct 23, 2024

Report 1924066-2024-00129 · MDR key 20793028

Device

Generic name

Reg O2 Cga870

Model number

32-29-2550ASTL

Catalog number

32-29-2550AU

Lot number

N/A

Product problems

  • Insufficient Device Problem Information
  • Insufficient Device Problem Information

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT SEEMS AN OXYGEN REGULATOR HAS EXPERIENCED AN IGNITION (FIRE) THAT WAS WELL CONTAINED WITHIN THE REGULATOR. THE ALLEGED IGNITION OCCURRED DURING AN EQUIPMENT CHECK AT THE START OF A SHIFT. AS IT HAD NO PATIENT IMPACT AND IT WAS AN ISSUE DISCOVERED DURING CHECKING AND THERE WERE NO OPERATOR INJURIES.

Additional Manufacturer Narrative

STILL AWAITING PRODUCT RETURN FOR INVESTIGATION. WE ONLY RECEIVED A PICTURE WITH OF THE OXYGEN REGULATOR THAT WAS INVOLVED IN THE INCIDENT.

Remedial action

  • Other