inforMED
MalfunctionMMC

HUDSON RCI

Received May 27, 2026 · Event occurred Apr 27, 2026

Report 1417592-2026-01799 · MDR key 25305889

Device

Generic name

Mask,oxygen,medium-concentration,7,sc

Catalog number

HUDRHO41U

Lot number

26BOA098

Product problems

  • Loose or Intermittent Connection

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE TUBING CONNECTION TO THE MASK IS EASILY DISCONNECTING AND THE FACE STRAP DOES NOT STAY IN PLACE. 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.

Description of Event or Problem

IT WAS REPORTED THAT THE TUBING CONNECTION TO THE MASK IS EASILY DISCONNECTING AND THE FACE STRAP DOES NOT STAY IN PLACE.