InnoSpire Elegance 00 (REF 1104624)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00383730003160), received between Mar 9, 2017 and Mar 1, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Degraded” (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.

• MalfunctionMar 1, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED AN INNOSPIRE ELEGANCE DEVICE FOR EVALUATION OF "LOW AIR FLOW". THERE WAS NO PATIENT HARM OR INJURY REPORTED. UPON RECEIPT OF THE DEVICE, THE MANUFACTURER NOTED PHYSICAL DAMAGE TO THE AC POWER SOURCE, WHICH RESULTED IN EXPOSED CONDUCTING WIRES, AND A RISK OF SHOCK TO THE USER. THERE WAS NO EVIDENCE OF THERMAL DAMAGE. ALTHOUGH THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS NOT CONFIRMED, THIS TYPE OF DAMAGE IS TYPICALLY A RESULT OF THE AC POWER CORD BEING SUBJECTED TO FORCES BEYOND INTENDED DESIGN. THE INNOSPIRE ELEGANCE DEVICE 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 CHILDREN AND ADULTS. LABELING WARNS THE USER "IT IS RECOMMENDED TO HAVE A BACKUP DEVICE FOR RESPIRATORY DELIVERY IN CASE A SITUATION ARISES WHEN YOUR NEBULIZER CAN NOT BE USED". THE USER IS ALSO CAUTIONED THAT 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). THIS DEVICE MEETS ALL RELEVANT UL AND IEC STANDARDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8383088 ↗
• MalfunctionMar 9, 2017Degraded; Degraded

  IT WAS REPORTED THAT THIS DEVICE HAD LOW AIR FLOW. ON RETURN OF THE DEVICE FOR EVALUATION, IT WAS NOTED THAT THE MAINS CORD HAD BEEN SEVERED AND THE PLUG WAS MISSING. THIS HAS LED TO EXPOSED MAINS WIRES, WHICH POSES NO HAZARD ITSELF AS THE DEVICE CANNOT NOW BE CONNECTED TO A MAINS SUPPLY. HOWEVER, IT HAS NOT BEEN ESTABLISHED HOW THE PLUG CAME TO BE MISSING, AND THERE IS A POSSIBILITY THAT IT BROKE OFF IN THE MAINS SOCKET - IF THIS WAS THE CASE THEN A RISK OF ELECTROCUTION WOULD BE CREATED. OUR EVALUATION CONCLUDED THAT IN ALL LIKELIHOOD THE CORD WAS SEVERED BY THE END USER APPLYING EXCESSIVE FORCE. INTERNAL REFERENCE (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6390703 ↗