MalfunctionBZE
VYAIRE MEDICAL CIRCUIT ADULT HTD VYAIRE 1 LIMB 8FT
Received Apr 1, 2026 · Event occurred Mar 25, 2026
Report MW5186269 · MDR key 24757987
Device
Generic name
Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer
Patient
28 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
AFTER 3 WEEKS OF USE, VYAIRE MEDICAL CIRCUIT ADULT HTD VYAIRE 1 LIMB 8FT (ITEM ID 4681-504) MELTED AT PART OF CIRCUIT THAT IS CLOSER TO THE MASK. NO HARM OCCURRED AND PRODUCT WAS EXCHANGED. PRODUCT WAS DISCARDED BY CAREGIVER, UNABLE TO OBTAIN LOT NUMBER PRIOR TO DISCARDING.