InnoSpire Elegance 00 (REF 1106648)Recalls & reported problems
Respironics Respiratory Drug Delivery (Uk) Ltd · Innospire Elegance, Custom Cornerstone Medical, 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 00383730002798), received between Apr 19, 2023 and Apr 19, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Power Up” (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.
Most reported problems
Device problems
- Failure to Power Up1
- Thermal Decomposition of Device1
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.
MalfunctionApr 19, 2023Thermal Decomposition of Device; Failure to Power Up; Thermal Decomposition of Device; Failure to Power Up
THE MANUFACTURER BECAME AWARE OF AN ALLEGATION THAT AN ELEGANCE NEBULIZER WOULD NOT POWER ON. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE MANUFACTURER RECEIVED THE DEVICE FOR EVALUATION AND COULD CONFIRM THE CUSTOMER'S ALLEGATION THAT THE DEVICE WOULD NOT TURN ON. IN ADDITION, IT WAS DETERMINED THERE WERE BURN MARKS INSIDE THE TOP CASING, THERMAL DAMAGE TO THE MOTOR PLASTIC CASING, AND EXPOSED WIRES DUE TO THERMAL DAMAGE. THIS REPORT WILL BE SUBMITTED AS AN INITIAL FINAL. THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NEEDED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16772018 ↗
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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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