InnoSpire Elegance 00 (REF 1099969)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00383730001623), received between Jan 6, 2023 and Dec 18, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Smoking” (2 reports).

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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Smoking; Smoking

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN INNOSPIRE ELEGANCE DEVICE WAS PLUGGED IN AND WAS NOT IN USE WHEN THE DEVICE STARTED SMOKING. THE DEVICE WAS PLUGGED INTO THE RECEPTACLE AND THE AC OUTLET. THERE IS NO SMOKE SMELL. THERE WERE NO REPORTS OF MELTING, WARPING OR VOIDS/GAPS IN ENCLOSURE. THERE ARE NO ALLEGATIONS OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23845541 ↗
• MalfunctionApr 25, 2025Thermal Decomposition of Device; Device Emits Odor; Smoking; Thermal Decomposition of Device; Device Emits Odor; Smoking

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING DREAMSTATION 2 ADV AUTO CPAP DEVICE EMITTED SMOKE AND A SMELLED LIKE BURNT PLASTIC. THE PATIENT REPORTS THE DEVICE CAUGHT FIRE WHEN THE PATIENT WAS USING THE DEVICE. THE PATIENT PLACED THE DEVICE ON THE FLOOR BECAUSE IT VIBRATED, AND THEY STARTED TO SMELL SOMETHING FUNNY. THE PATIENT REPORTS IT SMELLED LIKE BURNT PLASTIC AND NO FLAMES WERE SEEN. THE PATIENT SAW SMOKE COMING FROM INSIDE THE DEVICE. THE BOTTOM OF THE DEVICE AND SIDES ARE WARPED. THE VENTS ON THE SIDE ARE MELTED. THE PATIENT REPORTS USING A SURGE PROTECTOR. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21913100 ↗
• MalfunctionSep 14, 2023Power Problem; Power Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION THAT AN ELEGANCE NEBULIZER HAD A SHORT IN THE POWER CORD. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17745945 ↗
• MalfunctionAug 23, 2023Sparking; Noise, Audible; Sparking; Noise, Audible

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A THERMAL EVENT TO AN ELEGANCE NEBULIZER. THE USER ALLEGES THE DEVICE MADE A POPPING NOISE AND PRODUCED A SPARK. THERE WAS NO REPORT OF SMOKE OR FLAMES. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17602642 ↗
• MalfunctionJan 6, 2023Failure to Power Up; Failure to Power Up

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF AN ELEGANCE NEBULIZER THAT WAS NOT TURNING ON. THERE WAS NO PATIENT HARM OR INJURY, NO ALLEGATIONS OF THERMAL DAMAGE, NO VOIDS OR EXPOSED WIRES WERE REPORTED. THE MANUFACTURER RECEIVED THE DEVICE FOR INVESTIGATION AND CONFIRMED THE ALLEGATION OF DEVICE NOT TURNING ON. THERE WAS NO POWER DUE TO DAMAGE TO THE AC POWER CORD. WIRES WERE OUT OF THE STRAIN RELIEF, THE AC POWER CORD HAD EXPOSED COPPER CONDUCTORS. THERE WAS PHYSICAL DAMAGE TO THE CON-ROD, WHICH WAS DETACHED FROM THE COMPRESSOR. THERE WAS NO EVIDENCE OF THERMAL DAMAGE OR VOIDS TO THE ENCLOSURES. THIS REPORT WILL BE SUBMITTED AS AN INITIAL FINAL. THERE WAS NO PATIENT HARM OR INJURY. THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NEEDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16112565 ↗