inforMED
MalfunctionCAN

REGULATOR,O2,MINI 0-15 L,870 CGA

Received Jul 11, 2022 · Event occurred Jun 16, 2022

Report 1417592-2022-00099 · MDR key 14978270

Device

Generic name

Regulator,o2,mini 0-15 L,870 Cga

Catalog number

HCS8715M

Product problems

  • Fire

Patient

Unknown

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

Narrative

Description of Event or Problem

ACCORDING TO THE FACILITY WHEN THE REGULATOR WAS REMOVED FROM THE OLD OXYGEN TANK AND ATTACHED TO THE NEW OXYGEN TANK A 'FLASH OF FLAME CAME OUT WHEN THE OXYGEN WAS TURNED ON'.

Additional Manufacturer Narrative

ACCORDING TO THE FACILITY WHEN THE REGULATOR WAS REMOVED FROM THE OLD OXYGEN TANK AND ATTACHED TO THE NEW OXYGEN TANK A 'FLASH OF FLAME CAME OUT WHEN THE OXYGEN WAS TURNED ON'. PER THE FACILITY THE OXYGEN WAS TURNED OFF IMMEDIATELY AND A 'SMELL OF BURNING FILLED THE AIR'. ACCORDING TO THE FACILITY THE GREEN GASKET ON THE REGULATOR 'SMELLED OF SMOKE AND HAD A BURN ON THE SIDE'. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SAMPLE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.