MalfunctionCAF
InnoSpire Essence
Received Jul 27, 2026 · Event occurred Jul 14, 2026
Report 2518422-2026-039694 · MDR key 50015340
Device
Generic name
Nebulizer (direct Patient Interface)
Manufacturer
Respironics, Inc.Model number
1095060Catalog number
1095060
Product problems
- Thermal Decomposition of Device
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
The manufacturer received information alleging the Nebulizer device that the buttons melted and the bottom of device was melting as well. The patient said that the device was just hot to touch. There was no death, serious harm or injury, and no medical intervention was reported.