InnoSpire Elegance 00 (REF 1095059)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00383730001616), received between Apr 4, 2018 and Aug 24, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT THE BOTTOM OF AN INNOSPIRE ELEGANCE NEBULIZER MELTED. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE MANUFACTURER RECEIVED THE DEVICE FOR EVALUATION AND CONFIRMED THE INITIAL COMPLAINT OF THE BOTTOM OF THE NEBULIZER MELTED. THE DEVICE DID NOT HAVE ANY POWER WHEN PLUGGED IN TO THE AC OUTLET. THE TECHNICIAN VERIFIED THERE WAS THERMAL WARPING, HEAT DISCOLORATION, AND HEAVY FRICTION DAMAGE TO THE BOTTOM ENCLOSURE FROM THE PUMP FAN RUBBING AND CREATING A 2CM VOID. THE THERMAL FUSE BURNED ON THE MOTOR, THEN THE INLINE FUSE OPENED AS DESIGNED, PREVENTING AN ELECTRICAL THERMAL EVENT. THE TECHNICIAN WAS UNABLE TO DUPLICATE THE FAILURE OF THE NEBULIZER DUE TO THE DEVICE NOT HAVING ANY POWER. THIS APPEARS TO POSSIBLY BE CAUSED BY A MOTOR MISALIGNMENT ISSUE WHICH CAUSED THE FAN TO RUB AGAINST THE BOTTOM ENCLOSURE CREATING HEAVY FRICTION AND MOTOR-PUMP DESTABILIZATION WHICH LED TO THE THERMAL EVENT. THIS PRODUCT IS INTENDED TO PROVIDE A SOURCE OF COMPRESSED AIR FOR MEDICAL PURPOSES. IT IS TO BE USED WITH A PNEUMATIC (JET) NEBULIZER TO PRODUCE AEROSOL PARTICLES OF MEDICATION FOR RESPIRATORY THERAPY FOR BOTH CHILDREN AND ADULTS. THIS IS NOT A LIFE SU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15282745 ↗
• InjuryApr 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS DEVICE WAS NOT PUSHING THE MIST OUT WELL. IT WAS ALSO REPORTED THAT THE PATIENT WAS ADMITTED TO HOSPITAL FOR FLUID IN HER LUNGS, AND THE CAREGIVER STATES THAT HE FEELS THIS WAS BECAUSE THE PATIENT WAS NOT RECEIVING HER FULL TREATMENT. (B)(4).

  Patient problems: Pneumonia; Respiratory Distress

  MAUDE report 7395674 ↗