inforMED
MalfunctionCAN

MEDLINE

Received Jun 12, 2026 · Event occurred May 14, 2026

Report 1417592-2026-02406 · MDR key 25491601

Device

Generic name

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

Catalog number

HCS8715M

Product problems

  • Gas/Air Leak

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE IS LEAKING.

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE DEVICE IS LEAKING. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.