InnoSpire Elegance 00 (REF 1102828)Recalls & reported problems
Respironics Respiratory Drug Delivery (Uk) Ltd · Innospire Elegance with Sidestream Plus, 6 pack. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00383730002385), received between Nov 17, 2023 and Nov 17, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Emits Odor” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Emits Odor1
- Excessive Heating1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 17, 2023Device Emits Odor; Excessive Heating; Device Emits Odor; Excessive Heating
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO INNOSPIRE ELEGANCE DEVICE. THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE UNIT WAS HOT AND HAD A BURNING SMELL WHILE IN USE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. NO WARPING, MELTING, VOIDS/GAPS, SMOKE, OR FLAMES WERE REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER, AND DURING EVALUATION THE TECHNICIAN WAS UNABLE TO CONFIRM THE THERMAL EVENT. THE DEVICE WAS VISUALLY INSPECTED AND NO SIGNS OF THERMAL OR OTHER EVENTS WERE VISIBLE ON THE PLASTIC PARTS OF THE DEVICE. THE NPC FILTER WAS INSERTED AND DIRTY. THE NEBULIZER WAS CONNECTED TO TEST BENCH WHERE POWER WAS APPLIED AND THE DEVICE POWER'S ON, FAN SPINS, BUT PUMP ENGAGES, LIGHT AMOUNT OF MEDICINE DISPERSING INDICATING LITTLE TO NO PRESSURE. LIGHT ENVIRONMENTAL CONTAMINATION (THE INSIDE OF THE DEVICE APPEARS TO HAVE BEEN RECENTLY CLEANED): DIRT, DUST, AND DEBRIS ATTACHED TO THE FAN AND PUMP ASSEMBLY. NO NOTICEABLE THERMAL OR DAMAGE INSIDE THE DEVICE. UPON DISASSEMBLY OF THE UNIT VERIFYING ONLY LOW PRESSURE AT 1.4 PSI. THERE IS EVIDENCE OF LUBRICANT LEAKAGE, INTERNAL PUMP-CONTAMINATION, AND PISTON-SEAL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18166301 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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