InnoSpire Elegance 00 (REF 1099970)Recalls & reported problems
Respironics Respiratory Drug Delivery (Uk) Ltd · Innospire Elegance with SSR 230V 50HZ (AUS), 6-pack · Class 2
- 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 00383730001678), received between Jan 9, 2025 and Jan 9, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
Patient problems
- Malaise1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE ELEGANCE NEBULIZER DEVICE HAD MOLD IN THE DEVICE AND IN THE PATIENT'S TRACHEOSTOMY TUBE. IT WAS ALLEGED THE DEVICE CAUSED NON-SERIOUS INJURIES OF FEELING "UNWELL" ONCE THE PATIENT RESTARTED USING THE DEVICE. THE PATIENT REPORTED HAVING MEDICAL INTERVENTION OF "SPUTUM CULTURE, CHANGED TRACH TUBE, INCREASED CHEST PHYSIO TO CLEAR THE SPUTUM LOAD, AND WAS GIVEN A NEBULIZER VIA WARD DEVICE". THE MANUFACTURER'S INVESTIGATION IS ONGOING. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: Malaise
MAUDE report 21118498 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.