InnoSpire Elegance 00 (REF 1100134)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00383730001630), received between Jan 12, 2017 and Jan 6, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (3 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.

• MalfunctionJan 6, 2023Failure to Power Up; Failure to Power Up

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF UNIT HAS LOW FLOW FROM A DME REGARDING AN ELEGANCE NEBULIZER. THERE WAS NO REPORT OF PATIENT HARM OR INJURY, NO REPORT OF EXPOSED WIRES OR THERMAL ISSUES. THE MANUFACTURER RECEIVED THE DEVICE FOR INVESTIGATION. THE UNIT HAS NO POWER, SO WE ARE UNABLE TO CONFIRM THE COMPLAINT OF UNIT HAS LOW FLOW. THE AC POWER CORD HAS A FAULTY PLUG, ONE OF THE PRONGS HAS BROKEN OFF. THERE WAS NO EVIDENCE OF THERMAL DAMAGE, NO VOIDS OR DAMAGE TO THE ENCLOSURES. THERE WERE NO EXPOSED WIRES. 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 16113121 ↗
• MalfunctionMar 3, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF BARE WIRES COMING OUT OF ELEGANCE NEBULIZER. THERE WAS NO REPORT OF ANY THERMAL PROBLEMS. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE HAS NOT YET RETURNED FOR EVALUATION. THE INVESTIGATION IS ON-GOING. A FOLLOW UP FINAL WILL BE FILED ONCE THE INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13660966 ↗
• MalfunctionJul 26, 2017Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THIS DEVICE HAD EXPOSED WIRES. THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION SO WE ARE UNABLE TO CONFIRM ANY FAULT. HOWEVER, BASED ON THE REPORTED COMPLAINT, THE PATIENT MAY HAVE BEEN EXPOSED TO THE RISK OF ELECTROCUTION. THE IFU FOR THIS DEVICE CONTAINS THE WARNING 'THE POWER SUPPLY CORD CANNOT BE REPLACED BY THE USER. IN CASE THE POWER SUPPLY CORD BECOMES DAMAGED, CONTACT PHILIPS RESPIRONICS CUSTOMER SERVICE FOR REPLACEMENT (THERE IS NO SERVICE OPTION)'. NO PATIENT HARM OR DEATH HAS BEEN REPORTED AND THE DEVICE IS NOT LIFE SUSTAINING/SUPPORTING. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6743422 ↗
• MalfunctionJul 12, 2017Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE PRONGS ON THE PLUG OF THIS DEVICE REMAINED IN THE MAINS SOCKET WHEN THE PATIENT TRIED TO UNPLUG IT. ON RETURN OF THE DEVICE FOR EVALUATION, IT WAS CONFIRMED THAT BOTH PRONGS WERE MISSING FROM THE PLUG. IT WOULD THEREFORE APPEAR THAT A RISK OF ELECTROCUTION MAY HAVE BEEN CREATED BY HAVING METAL PRONGS PROTRUDING FROM A LIVE MAINS SOCKET. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6705126 ↗
• MalfunctionJan 12, 2017Fire; Fire

  IT WAS ALLEGED THAT THIS DEVICE CAUGHT ON FIRE AND MELTED. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6245008 ↗