InnoSpire Elegance 00 (REF 1099973)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00383730001715), received between Feb 15, 2017 and Dec 29, 2023 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (13 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF ELEGANCE WITH SSR THAT THE PATIENT ALLEGES THAT THE DEVICE DOES NOT GENERATE MIST. 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 18416971 ↗
• MalfunctionNov 21, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION THAT AN INNOSPIRE ELEGANCE DEVICE WITH A STRANGE SMELL AS IF SOMETHING IS BURNING. 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 18185496 ↗
• MalfunctionNov 10, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  THE MANUFACTURER RECEIVED THIS DEVICE FOR EVALUATION IN RESPONSE TO A USERS REPORT OF "PHYSICAL DAMAGE". THERE WAS NO PATIENT HARM OR INJURY REPORTED. UPON RECEIPT OF THE DEVICE, THE MANUFACTURER NOTED THE AC CORD PLASTIC OUTER COATING IS SPLIT, EXPOSING WIRES. THE AC CORD WAS TAPED UP. THE REPORTED COMPLAINT OF PHYSICAL DAMAGE WAS CONFIRMED. LABELING WARNS THE "IT IS RECOMMENDED TO HAVE A BACKUP DEVICE FOR RESPIRATORY DELIVERY IN CASE A SITUATION ARISES WHEN YOUR NEBULIZER CAN NOT BE USED". THIS DEVICE MEETS ALL RELEVANT UL AND IEC STANDARDS. THIS DEVICE IS NOT LABELED FOR LIFE SUPPORT. BASED ON THE INFORMATION AVAILABLE, THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12790574 ↗
• MalfunctionOct 28, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  THE MANUFACTURER RECEIVED THIS DEVICE FOR EVALUATION IN RESPONSE TO A USERS REPORT OF "PHYSICAL DAMAGE". THERE WAS NO PATIENT HARM OR INJURY REPORTED. UPON RECEIPT OF THE DEVICE, THE MANUFACTURER NOTED THE AC CORD PLASTIC OUTER COATING IS SPLIT, EXPOSING WIRES. THE AC CORD WAS TAPED UP. THE REPORTED COMPLAINT OF PHYSICAL DAMAGE WAS CONFIRMED. LABELING WARNS THE "IT IS RECOMMENDED TO HAVE A BACKUP DEVICE FOR RESPIRATORY DELIVERY IN CASE A SITUATION ARISES WHEN YOUR NEBULIZER CAN NOT BE USED". THIS DEVICE MEETS ALL RELEVANT UL AND IEC STANDARDS. THIS DEVICE IS NOT LABELED FOR LIFE SUPPORT. BASED ON THE INFORMATION AVAILABLE, THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12713125 ↗
• InjuryOct 12, 2021Smoking; Smoking

  THE MANUFACTURER RECEIVED INFORMATION FROM (B)(6) REGARDING AN ALLEGATION AN INNOSPIRE ELEGANCE COMPRESSOR BEGAN EMITTING THICK SMOKE WHILE IN USE. THE USER WAS REPORTEDLY HOSPITALIZED WITH OXYGEN DESATURATION AND UNSPECIFIED RESPIRATORY PROBLEMS. THE USER WAS DISCHARGED THE SAME DAY WITH A NORMAL OXYGEN SATURATION AND NO AFTER EFFECTS FROM THE REPORTED EVENT. THE MANUFACTURER'S INVESTIGATION IS ON-GOING. RETURN OF THE DEVICE FOR INVESTIGATION HAS BEEN REQUESTED. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION.

  Patient problems: Low Oxygen Saturation; Unspecified Respiratory Problem

  MAUDE report 12618957 ↗
• MalfunctionAug 11, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED THIS DEVICE FOR EVALUATION FROM A DISTRIBUTOR IN (B)(6) FOR A REPORT OF "PHYSICAL DAMAGE". UPON EVALUATION, THE REPORTED FAULT OF PHYSICAL DAMAGE WAS CONFIRMED. THERE WERE EXPOSED WIRES ON THE AC POWER CORD. THE ROOT CAUSE OF THIS FAILURE IS TYPICALLY DUE TO THE CORD BEING EXPOSED TO FORCES BEYOND ITS INTENDED DESIGN. THE INNOSPIRE ELEGANCE DEVICE IS INTENDED TO PROVIDE A SOURCE OF COMPRESSED AIR FOR MEDICAL PURPOSES. IT IS TO BE USED WITH APNEUMATIC (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".THIS DEVICE MEETS ALL RELEVANT UL AND IEC STANDARDS. THIS DEVICE IS NOT LABELED FOR LIFE SUPPORT. BASED ON THE INFORMATION AVAILABLE, THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12306523 ↗
• MalfunctionApr 21, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED THIS DEVICE FOR EVALUATION FROM A DISTRIBUTOR IN (B)(4) FOR A REPORT OF "DOES NOT TURN ON". UPON EVALUATION, IT WAS NOTED THERE WAS PHYSICAL DAMAGE TO THE AC POWER CORD, WITH EVIDENCE OF EXPOSURE TO THE CONDUCTING WIRES. THE EXACT DATE THE PHYSICAL DAMAGE OCCURRED WAS NOT REPORTED BY THE DISTRIBUTOR. THE REPORTED FAULT OF "DOES NOT TURN ON" WAS CONFIRMED. THE ROOT CAUSE OF THIS FAILURE IS TYPICALLY DUE TO THE CORD BEING EXPOSED 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".THIS DEVICE MEETS ALL RELEVANT UL AND IEC STANDARDS. THIS DEVICE IS NOT LABELED FOR LIFE SUPPORT. BASED ON THE INFORMATION AVAILABLE, THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11699547 ↗
• MalfunctionApr 16, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED AN INNOSPIRE ELEGANCE DEVICE FOR EVALUATION DUE TO A REPORT OF "PHYSICAL DAMAGE". THERE WAS NO PATIENT INVOLVEMENT REPORTED. UPON RECEIPT, THE MANUFACTURER NOTED PHYSICAL DAMAGE TO THE AC POWER CORD, WITH EXPOSURE TO THE CONDUCTING WIRES. 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). THE MANUFACTURER WILL CONTINUE TO MONITOR THE COMPLAINT RECORDS FOR SIMILAR REPORTED FAILU

  Patient problems: No Patient Involvement

  MAUDE report 9968886 ↗
• MalfunctionOct 8, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS DEVICE WAS RETURNED WITHOUT ANY SPECIFIC FAULT REPORTED. ON RETURN OF THE DEVICE FOR EVALUATION, IT WAS OBSERVED THAT THE MAINS CABLE WAS DAMAGED TO THE EXTENT THAT BARE WIRES WERE VISIBLE. BASED ON THIS THE PATIENT MAY HAVE BEEN EXPOSED TO THE RISK OF ELECTROCUTION. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7942367 ↗
• MalfunctionJun 6, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THIS DEVICE HAD A BROKEN COVER. ON RETURN OF THE DEVICE FOR EVALUATION IT WAS OBSERVED THAT THE MAINS CORD WAS DAMAGED TO THE EXTENT THAT BARE COPPER WIRES WERE EXPOSED. THE CUSTOMER HAS BEEN APPROACHED WITH A VIEW TO IDENTIFYING HOW THIS DAMAGE OCCURRED, BUT TO DATE THEY HAVE NOT PROVIDED ANY FURTHER INFORMATION. BASED ON THIS, THE PATIENT MAY HAVE BEEN EXPOSED TO THE RISK OF ELECTROCUTION. THE COVER WAS NOT BROKEN. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7572835 ↗
• MalfunctionJun 6, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THIS DEVICE WAS BROKEN. ON RETURN OF THE DEVICE FOR EVALUATION IT WAS OBSERVED THAT THE MAINS CORD WAS DAMAGED TO THE EXTENT THAT BARE COPPER WIRES WERE EXPOSED. THE CUSTOMER HAS BEEN APPROACHED WITH A VIEW TO IDENTIFYING HOW THIS DAMAGE OCCURRED, BUT TO DATE THEY HAVE NOT PROVIDED ANY FURTHER INFORMATION. BASED ON THIS, THE PATIENT MAY HAVE BEEN EXPOSED TO THE RISK OF ELECTROCUTION. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7572819 ↗
• MalfunctionMar 14, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING INHALATION THE POWER CORD ON THIS DEVICE STARTED TO SMOKE AND BURN. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, BUT THE CUSTOMER HAS SUPPLIED PHOTOS WHICH INDICATE THAT THE MAINS CORD HAS SUFFERED SOME HEAT DAMAGE, AND THIS HAS LED TO THE OUTER SHEAVING AND THE INSULATION ON THE NEUTRAL WIRE BEING DAMAGED TO THE EXTENT THAT BARE WIRES ARE EXPOSED. BASED ON THIS, THE PATIENT MAY HAVE BEEN EXPOSED TO THE RISK OF ELECTROCUTION. THERE IS ALSO EVIDENCE OF OTHER PHYSICAL DAMAGE TO THE MAINS CORD VISIBLE ON THE CUSTOMER'S PHOTOS. THE CUSTOMER STATES THAT THEY CANNOT REMEMBER ANY PHYSICAL OR VISIBLE DAMAGE TO THE CABLE BEFORE THE EVENT, BUT ADVISES THAT THE DEVICE WOULD LOSE POWER DURING INHALATION, AND THE POWER WOULD BE RETURN WHEN THE CABLE WAS TOUCHED. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7337645 ↗
• MalfunctionFeb 20, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THIS DEVICE WAS BROKEN AND HAD LOW PRESSURE. ON RETURN OF THE DEVICE FOR EVALUATION IT WAS OBSERVED THAT THE MAINS CORD WAS DAMAGED TO THE EXTENT THAT BARE COPPER WIRES WERE EXPOSED. THE CUSTOMER HAS BEEN APPROACHED WITH A VIEW TO IDENTIFYING HOW THIS DAMAGE OCCURRED, BUT TO DATE THEY HAVE NOT PROVIDED ANY FURTHER INFORMATION. BASED ON THIS, THE PATIENT MAY HAVE BEEN EXPOSED TO THE RISK OF ELECTROCUTION. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7281614 ↗
• MalfunctionFeb 20, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THIS DEVICE HAD LOW PRESSURE. ON RETURN OF THE DEVICE FOR EVALUATION IT WAS OBSERVED THAT THE MAINS CORD WAS DAMAGED TO THE EXTENT THAT BARE COPPER WIRES WERE EXPOSED. THE CUSTOMER HAS BEEN APPROACHED WITH A VIEW TO IDENTIFYING HOW THIS DAMAGE OCCURRED, BUT TO DATE THEY HAVE NOT PROVIDED ANY FURTHER INFORMATION. BASED ON THIS, THE PATIENT MAY HAVE BEEN EXPOSED TO THE RISK OF ELECTROCUTION. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7281612 ↗
• MalfunctionJan 12, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THIS DEVICE WAS NOT WORKING. ON RETURN OF THE DEVICE FOR EVALUATION IT WAS OBSERVED THAT THE MAINS CORD WAS DAMAGED TO THE EXTENT THAT BARE COPPER WIRES WERE EXPOSED, AND THAT THE PLUG HAD BEEN REMOVED. BASED ON THIS, 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. INTERNAL REFERENCE RA (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7185183 ↗
• MalfunctionDec 5, 2017Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THIS DEVICE HAD LOW PRESSURE. ON RETURN OF THE DEVICE FOR EVALUATION IT WAS OBSERVED THAT THE MAINS CORD WAS DAMAGED TO THE EXTENT THAT BARE COPPER WIRES WERE EXPOSED. BASED ON THIS, 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 7082015 ↗
• MalfunctionOct 20, 2017Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THIS DEVICE HAD LOW PRESSURE. ON RETURN OF THE DEVICE FOR EVALUATION IT WAS OBSERVED THAT THE MAINS CORD WAS DAMAGED TO THE EXTENT THAT BARE COPPER WIRES WERE EXPOSED. BASED ON THIS, 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 6964975 ↗
• MalfunctionMay 26, 2017Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THIS DEVICE WAS DEFECTIVE. ON RETURN OF THE DEVICE FOR EVALUATION, IT WAS NOTED THAT ONE PRONG WAS MISSING FROM THE PLUG, AND THE OTHER WAS BENT. THE CUSTOMER HAS BEEN APPROACHED WITH A VIEW TO CONFIRMING HOW THE PLUG CAME TO BE IN THIS CONDITION, BUT NO RESPONSE HAS BEEN RECEIVED. ALTHOUGH IT HAS NOT BEEN ESTABLISHED HOW THE PRONG CAME TO BE MISSING, THERE IS A POSSIBILITY THAT IT BROKE OFF IN THE MAINS SOCKET WHEN THE PLUG WAS REMOVED - IF THIS WAS THE CASE THEN A RISK OF ELECTROCUTION WOULD BE CREATED. THE MOST LIKELY EXPLANATION FOR ANY SUCH CONCERN WOULD BE THAT THE PLUG WOULD HAVE BEEN DAMAGED BY THE END USER APPLYING EXCESSIVE FORCE. THERE IS NO REPORT OF ANY PATIENT HARM. THE DEVICE IS NOT LIFE-SUPPORTING OR LIFE-SUSTAINING. INTERNAL REFERENCE RA (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6593510 ↗
• MalfunctionFeb 15, 2017Degraded; Degraded

  IT WAS REPORTED THAT THIS DEVICE HAD LOW PRESSURE. ON RECEIPT OF THE DEVICE FOR EVALUATION IT WAS APPARENT THAT THE MAINS LEAD WAS DAMAGED, LEADING TO EXPOSED WIRES. THE CUSTOMER WAS APPROACHED WITH REGARD TO CONFIRMING HOW THIS DAMAGE OCCURRED, BUT THEY WERE UNABLE TO PROVIDE ADDITIONAL INFORMATION. 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 6331336 ↗