MalfunctionBYG
AIRLIFE¿
Received Apr 9, 2025 · Event occurred Mar 18, 2025
Report 21804596 · MDR key 21804596
Device
Generic name
Mask, Oxygen
Manufacturer
Sunmed Group Holdings, Llc Dba AirlifeModel number
001268UCatalog number
001268U
Product problems
- Defective Component
- Connection Problem
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
END PIECE TO THE TUBING WITHIN THE 3 IN 1 BAG WAS ABNORMAL. IT WOULD NOT ATTACH TO THE MASK. IT ATTACHED APPROPRIATELY TO THE OXYGEN SOURCE. WHEN TRYING TO ATTACH TUBING TO MASK, THE END WAS VERY ROUND/WIDE COMPARED TO HOW IT NORMALLY LOOKS AND IT KEPT FALLING OFF.