InnoSpire Essence 00 (REF 1112261)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00383730001951), received between Jul 21, 2017 and Mar 13, 2025 — classified as 8 deaths, 5 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• DeathMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH AN ESSENCE DEVICE HAS PASSED AWAY. THERE WAS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. THE DEVICE IS MISSING AND UNAVAILABLE FOR RETURN TO THE MANUFACTURER FOR INVESTIGATION. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21593768 ↗
• DeathFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH AN ESSENCE DEVICE HAS PASSED AWAY. THERE WAS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. THE DEVICE IS MISSING AND UNAVAILABLE FOR RETURN TO THE MANUFACTURER FOR INVESTIGATION. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21313272 ↗
• MalfunctionNov 8, 2024Failure to Power Up; Adverse Event Without Identified Device or Use Problem; Failure to Power Up; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE DEVICE WAS NOT SWITCHING ON AND NOT DELIVERING THE TREATMENT TO THE PATIENT. IT WAS REPORTED THAT TROUBLESHOOTING WAS DONE THE DEVICE WAS PLUGGED INTO POWER, TUBING WAS FIXED AND THEN THE DEVICE WAS TRIED AGAIN. THE EVENT OCCURRED ONCE. 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 20646591 ↗
• DeathSep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH AN INNOSPIRE ESSENCE DEVICE HAS PASSED AWAY. THERE WAS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. THE DEVICE IS MISSING AND UNAVAILABLE FOR RETURN TO THE MANUFACTURER FOR INVESTIGATION. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20311138 ↗
• DeathSep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A ESSENCE RENTAL WITH SSD 230 DEVICE. THE PATIENT HAS ALLEGEDLY PASSED AWAY. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.

  Patient problems: Insufficient Information

  MAUDE report 20311002 ↗
• DeathSep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO AN ESSENCE DEVICE. THERE WAS AN ALLEGATION OF PATIENT PASSING AWAY. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 20306276 ↗
• DeathJun 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH AN INNOSPIRE ESSENCE DEVICE HAS PASSED AWAY. THERE WAS NO ALLEGATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH. THE DEVICE IS MISSING AND UNAVAILABLE FOR RETURN TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19480987 ↗
• DeathJun 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH AN INNOSPIRE ESSENCE DEVICE HAS PASSED AWAY. THERE WAS NO ALLEGATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH. THE DEVICE IS MISSING AND UNAVAILABLE FOR RETURN TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19480514 ↗
• DeathJun 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH AN INNOSPIRE ESSENCE DEVICE HAS PASSED AWAY. THERE WAS NO ALLEGATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH. THE DEVICE IS MISSING AND UNAVAILABLE FOR RETURN TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19480350 ↗
• 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 "FAULTY NEB" AND "POWER LEAD IS DAMAGED". 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 REPORTED COMPLAINTS OF "FAULTY NEB" AND "POWER LEAD IS DAMAGED" WAS CONFIRMED. LABELING WARNS THE USER THAT THE POWER SUPPLY CORD (AC) CANNOT BE REPLACED BY THE USER. IF THE POWER CORD BECOMES DAMAGED, THE USER IS INSTRUCTED TO CONTACT THEIR PROVIDER OR THE MANUFACTURER FOR REPLACEMENT, AS THERE IS NO SERVICE OPTION. THIS DEVICE MEETS ALL RELEVANT UL AND IEC STANDARDS. BASED ON THE INFORMATION AVAILABLE, THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12713130 ↗
• MalfunctionOct 3, 2018Degraded; Degraded

  IT WAS REPORTED THAT THIS DEVICE WAS GETTING WARM AND SMOKING. ON RETURN OF THE DEVICE FOR EVALUATION, NO HEAT DAMAGE WAS OBSERVED INSIDE OR OUTSIDE THE DEVICE. HOWEVER, IT WAS OBSERVED THAT THE MAINS CABLE WAS DAMAGED TO THE EXTENT THAT BARE WIRES WERE VISIBLE, POTENTIALLY EXPOSING THE PATIENT TO THE RISK OF ELECTROCUTION. NO INFORMATION HAS BEEN PROVIDED AS TO HOW THE MAINS CORD CAME TO BE IN THIS CONDITION. 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 7929179 ↗
• MalfunctionAug 3, 2017Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THIS DEVICE STOPPED WORKING. ON RETURN OF THE DEVICE FOR EVALUATION IT WAS OBSERVED THAT THE STRAIN RELIEF ON THE MAINS CORD WAS NOT SITTING IN ITS RECESS, AND THE INSULATION ON 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 6763486 ↗
• MalfunctionJul 21, 2017Degraded; Degraded

  IT WAS REPORTED THAT THIS DEVICE HAD NO FLOW/PRESSURE. ON RECEIPT OF THE DEVICE FOR EVALUATION IT WAS APPARENT THAT THE MAINS LEAD WAS DAMAGED, LEADING TO EXPOSED WIRES. WE HAVE NOT RECEIVED ANY INFORMATION FROM THE CUSTOMER AS TO HOW THE DEVICE CAME TO BE IN THIS CONDITION. 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 6731180 ↗