MalfunctionCAF
ESSENCE
Received Jun 1, 2026 · Event occurred May 14, 2026
Report 2518422-2026-018102 · MDR key 25352771
Device
Generic name
Nebulizer (direct Patient Interface)
Manufacturer
Respironics, Inc.Model number
1099966Catalog number
1099966
Product problems
- Overheating of Device
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO AN ESSENCE DEVICE. THERE WAS AN ALLEGATION THAT PART OF THE NEB MELTED AND THE ONE TUBING THAT GOES TO THE AIR PART KEPT COMING OFF. THE DEVICE SMELLED LIKE MEDICINE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.