InnoSpire Essence 00 (REF 1095060)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00383730001807), received between Jul 19, 2018 and Mar 11, 2026 — classified as 1 death, 7 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• DeathMar 11, 2026Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH AN INNOSPIRE ESSENCE NEBULIZER HAS PASSED AWAY. IT WAS ALLEGED THE NEBULIZER WAS DEFECTIVE AND STATED THAT THE DEVICE WAS SUBSEQUENTLY RECALLED. IT IS ALLEGED THAT USE OF THE DEVICE CAUSED OR CONTRIBUTED TO WORSENING OF THE PATIENT¿S RESPIRATORY CONDITION. THE PATIENT SUBSEQUENTLY PASSED ON (B)(6) 2025. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED

  Patient problems: Respiratory Failure

  MAUDE report 24571611 ↗
• MalfunctionJul 23, 2024Failure to Power Up; Smoking; Failure to Power Up; Smoking

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO AN ASSAY FOR ESSENCE PLUG DEVICE WITH ALLEGATION OF DEVICE IS SMOKING AND NOT TURNING ON. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. 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 19804822 ↗
• MalfunctionMay 2, 2024Failure to Deliver; Failure to Deliver

  THE MANUFACTURER BECAME AWARE OF A USER OF AN ESSENCE NEBULIZER ALLEGING THAT MEDICATION WAS NOT COMING OUT OF THE DEVICE. THE PATIENT STATES THAT THEY RECENTLY REPLACED THE FILTER AND CLEANED THE PARTS FOLLOWING THE INSTRUCTIONS. THERE WAS NO REPORT OF SERIOUS HARM OR INJURY. 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 19230935 ↗
• MalfunctionNov 16, 2023Unexpected Shutdown; Unexpected Shutdown

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT THE NEBULIZER STOPPED RUNNING DURING THERAPY. IT WAS ALSO MENTIONED THAT THE DEVICE WAS ABOUT 3 YEARS OLD. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. 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 18146186 ↗
• MalfunctionOct 28, 2022Electrical /Electronic Property Problem; Contamination /Decontamination Problem; Electrical /Electronic Property Problem; Contamination /Decontamination Problem

  THE MANUFACTURER BECAME AWARE THAT AN ESSENCE NEBULIZER WAS NOT WORKING. THERE WAS NO REPORT OF SMOKING, FLAMES OR EXPOSED WIRES. THE NEBULIZER WAS RETURNED FOR EVALUATION AND THE TECHNICIAN FOUND EVIDENCE OF A MILKY CONTAMINATE THROUGHOUT THE INSIDE AND OUTSIDE OF THE DEVICE. IT APPEARS THE LIQUID CONTAMINATION MADE ITS WAY INSIDE THE SWITCH FROM THE TOP OF THE ENCLOSURE CAUSING VERDIGRIS AND A SHORT. THIS SHORT MELTED THE INTERNAL POWER CABLES AT THE ON/OFF SWITCH, AND MELTED INTO THE NPC BUFFER TUBE CAUSING A HOLE IN THE BUFFER CYLINDER AND DAMAGED THE SURROUNDING AREA. THERE WAS NO ALLEGATIONS OF HARM OR INJURY. THE MANUFACTURER CONFIRMED THE COMPLAINT OF DEVICE NOT WORKING DUE TO THE THERMAL DAMAGE INSIDE THE MACHINE AT THE ON/OFF SWITCH. THE ROOT CAUSE COULD BE THE SWITCH ITSELF HAD AN INTERNAL SHORT, THE INSULATED CONNECTION TABS AS THE END OF THE WHITE AND BLACK INTERNAL POWER WIRES MAY HAVE HAD A FUILURE OR THE LIQUID CONTAMINATION HAD CAUSED THE THERMAL EVENT. THE NEBULIZER HAD EVIDENCE OF GRIME, DIRT, DEBRIS AND A BLACK POWDERY SUBSTANCE FALLING FROM THE VENTS. THERE WAS NO AIR FILTER IN PLACE. LABELING WARNS: ANY LIQUID SPILLED ON OR INSIDE THE UNIT SHOULD BE ALLOWED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15692566 ↗
• MalfunctionFeb 9, 2021Material Split, Cut or Torn; Unexpected Shutdown; Material Split, Cut or Torn; Unexpected Shutdown

  THE MANUFACTURER RECEIVED A REPORT OF A POSSIBLE THERMAL EVENT TO AN INNOSPIRE ESSENCE NEBULIZER. THE USER REPORTED SHE HIT THE POWER BUTTON, THE DEVICE STOPPED WORKING AND A SECTION OF THE POWER CORD STARTED TO SMOKE. THERE WAS EVIDENCE OF EXPOSED WIRES ON THE POWER CORD. THERE WAS NO REPORT OF FLAMES, OR DAMAGE TO THE NEBULIZER. THERE WAS NO PATIENT HARM OR INJURY ASSOCIATED WITH THIS REPORTED EVENT. UPON RECEIPT OF THE DEVICE, THE MANUFACTURER FOUND THE DEVICE WORKING AS DESIGNED. THE POWER CORD REVEALED A CUT OR PINCHED MIDDLE SECTION WITH THE EXPOSED BARE INNER WIRES WITH EVIDENCE OF MELTING. THE ROOT CAUSE OF THE EVENT WAS UNABLE TO BE DETERMINED, HOWEVER, IT IS LIKELY THE AC POWER CORD HAD BEEN EXPOSED TO FORCES BEYOND INTENDED DESIGN. THERE WERE NO VOIDS TO THE ENCLOSURE, NO THERMAL DAMAGE TO THE ACTUAL NEBULIZER. THE INNOSPIRE ESSENCE 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 DEVICE IS NOT LABELED FOR LIFE SUPPORT. LABELING INCLUDED WITH THE DEVICE WARNS THE USER, "IT IS RECOMMENDED TO HAVE A B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11304859 ↗
• MalfunctionApr 14, 2020Fire; Fire

  THE MANUFACTURER WAS MADE AWARE BY AN END USER THAT A THERMAL EVENT OCCURRED WITH AN INNOSPIRE ESSENCE DEVICE. THERE WAS NO PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT. THE USER REPORTED THAT THE MACHINE WAS TURNED ON AND IN USE WHEN THEY NOTICED THE DEVICE BEGAN TO SMOKE AND FLAMES WERE COMING FROM THE DEVICE. THE USER UNPLUGGED THE DEVICE AND TOOK IT OUTSIDE WHERE THE FLAMES THEN SELF-EXTINGUISHED. THE MANUFACTURER REQUESTED THE RETURN OF THE DEVICE FOR INVESTIGATION; HOWEVER, THE USER DISPOSED OF THE DEVICE AND WILL NOT BE RETURNING IT TO THE MANUFACTURER. THE ROOT CAUSE OF THE REPORTED EVENT IS UNABLE TO BE CONFIRMED. 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 SUPPORT DEVICE. THE USER IS WARNED IN THE LABELING TO HAVE A BACKUP DEVICE FOR RESPIRATORY DELIVERY IF THIS DEVICE IS NOT OPERABLE. BASED ON THE INFORMATION AVAILABLE, THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NECESSARY, AND WILL CONTINUE TO MONITOR COMPLAINTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9957768 ↗
• MalfunctionJul 19, 2018Degraded; Degraded

  IT WAS REPORTED THAT THIS DEVICE HAD EXPOSED WIRE. ON RECEIPT OF THE DEVICE FOR EVALUATION IT WAS OBSERVED THAT THE MAINS CORD WAS DAMAGED LEADING TO EXPOSED WIRES. 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 7702222 ↗