InnoSpire Essence 00 (REF 1099966)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00383730001814), received between Jun 9, 2017 and Jan 31, 2024 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fire” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2024Failure to Deliver; Failure to Deliver

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO AN INNOSPIRE ESSENCE DEVICE. THE REPORTER STATED THE LIQUID (MEDICATION) IN THE DEVICE WOULD NOT CONVERT TO MIST. 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 18620049 ↗
• MalfunctionMar 16, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  THE MANUFACTURER RECEIVED THIS DEVICE FOR EVALUATION IN RESPONSE TO A USER'S REPORT OF "NO POWER". THERE WAS NO INITIAL REPORT OF EXPOSED WIRING. THE EXACT DAY OF THE REPORTED EVENT IS UNKNOWN. UPON RECEIPT OF THE DEVICE, THE MANUFACTURER NOTED THE AC CORD WAS STRETCHED OUT BY THE STRAIN RELIEF AT THE NEBULIZER, WITH EXPOSURE TO DAMAGED ELECTRICAL WIRES. THERE IS NO EVIDENCE OF THERMAL DAMAGE ON THE INNER WIRES. 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. 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. LABELING INCLUDED WITH THE DEVICE WARNS THE USER, "IT IS RECOMMENDED TO HAVE A BACKUP DEVICE (E.G. MDI OR BATTERY-OPERATED COMPRESSOR) FOR RESPIRATORY DELIVERY IN CASE A SITUATION ARISES WHEN YOUR NEBULIZER CANNOT BE USED (E.G. DURING A POWER OUTAGE OR IF YOUR COMPRESSOR BECOMES INOPERABLE FOR ANY REASON)." LABELING ALSO WARNS THE USER THAT THE POWER SUPPLY CORD CANNOT BE REPLACED BY THE USER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11496536 ↗
• MalfunctionJan 14, 2021Fire; Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED A REPORT OF A POSSIBLE THERMAL EVENT TO AN INNOSPIRE ESSENCE NEBULIZER. THE USER REPORTED HE WAS USING THE NEBULIZER AND THEN SHUT IT OFF. WHEN HE CAME BACK INTO THE ROOM, THE NEBULIZER ALLEGEDLY WAS ON FIRE. HE UNPLUGGED THE NEBULIZER AND THREW IT OUTSIDE. THERE WAS NO PATIENT HARM OR INJURY REPORTED. THE MANUFACTURE'S INVESTIGATION IS ON-GOING. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11170193 ↗
• MalfunctionNov 10, 2020Fire; Smoking

  THE MANUFACTURER RECEIVED A REPORT OF A POSSIBLE THERMAL EVENT TO AN INNOSPIRE ESSENCE NEBULIZER. THE DEVICE ALLEGEDLY STARTED SMOKING AND FLAMES WERE SEEN AT THE POWER CORD WHILE THE PATIENT WAS USING THE DEVICE. THE PATIENT UNPLUGGED THE DEVICE AND THE FLAMES WENT OUT. THERE WAS NO PATIENT HARM OR INJURY REPORTED. THE MANUFACTURER'S INVESTIGATION IS ON-GOING. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10816081 ↗
• MalfunctionJun 10, 2020Fire; Smoking; Fire; Smoking

  THE MANUFACTURER RECEIVED A REPORT OF A POSSIBLE THERMAL EVENT TO AN INNOSPIRE ESSENCE NEBULIZER. THE DEVICE ALLEGEDLY STARTED SMOKING AND FLAMES WERE SEEN WHILE THE PATIENT WAS USING THE DEVICE. THE PATIENT UNPLUGGED THE DEVICE AND THREW IT OUTSIDE. THERE WAS NO PATIENT HARM OR INJURY REPORTED. THE PATIENT DISCARDED THE DEVICE. THE SERIAL NUMBER AND LOT NUMBER ARE MISSING, THEREFORE THE DATE OF MANUFACTURE IS UNABLE TO BE DETERMINED. THE EXACT DATE OF THE REPORTED EVENT IS UNKNOWN. 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 IS NOT A LIFE SUPPORT DEVICE. LABELING INCLUDED WITH THE DEVICE WARNS THE USER, "IT IS RECOMMENDED TO HAVE A BACKUP DEVICE (E.G. MDI OR BATTERY-OPERATED COMPRESSOR) FOR RESPIRATORY DELIVERY IN CASE A SITUATION ARISES WHEN YOUR NEBULIZER CANNOT BE USED (E.G. DURING A POWER OUTAGE OR IF YOUR COMPRESSOR BECOMES INOPERABLE FOR ANY REASON)." THE MANUFACTURER WILL CONTINUE TO MONITOR THE COMPLAINT RECORDS FOR SIMILAR REPORTED FAILURES. BASED ON THE AVAILABLE INFORMATI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10138582 ↗
• InjuryJan 24, 2018Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THIS DEVICE WOULD TURN ON, BUT NOT GIVE MEDICATION. AS A RESULT, THE PATIENT ATTENDED EMERGENCY ROOM (ER) TO GET MEDICINE TREATMENT. HE RECEIVED 2 BREATHING TREATMENTS AND WAS GIVEN A SCRIPT FOR ORAL STERIODS. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION SO WE ARE UNABLE TO CONFIRM ANY DEFECT. INTERNAL REFERENCE RA 307144548.

  Patient problems: Respiratory Distress

  MAUDE report 7214656 ↗
• MalfunctionJul 12, 2017Cut In Material; Cut In Material

  IT WAS REPORTED THAT THE MAINS CORD OF THIS DEVICE WAS BROKEN. ON RECEIPT OF THE DEVICE FOR EVALUATION IT WAS OBSERVED THAT THE MAINS CORD WAS SEVERED LEADING TO EXPOSED WIRES. IT APPEARS AS THOUGH THE CORD WAS INTENTIONALLY CUT, AND THE CUSTOMER WAS APPROACHED WITH REGARD TO CONFIRMING THIS ASSERTION. THEY HAVE NOT PROVIDED ANY FURTHER INFORMATION REGARDING 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)'. INTERNAL REFERENCE: (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6705121 ↗
• MalfunctionJul 10, 2017Degraded; Degraded

  IT WAS REPORTED THAT THE CORD OF THIS DEVICE WAS CUT. ON RECEIPT OF THE DEVICE FOR EVALUATION IT WAS OBSERVED THAT THE MAINS CORD WAS SEVERELY DAMAGED, LEADING TO EXPOSED WIRES. IT APPEARS AS THOUGH THE MAINS CORD HAD BEEN SUBJECTED TO CONSIDERABLE EXTERNAL STRESS, AND THE CUSTOMER WAS APPROACHED WITH REGARD TO CONFIRMING THIS ASSERTION. THEY HAVE NOT PROVIDED ANY FURTHER INFORMATION REGARDING 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)'. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6696377 ↗
• MalfunctionJul 10, 2017Cut In Material; Cut In Material

  IT WAS REPORTED THAT THIS DEVICE HAD A BROKEN CORD. ON RECEIPT OF THE DEVICE FOR EVALUATION IT WAS OBSERVED THAT THE MAINS CORD WAS SEVERED LEADING TO EXPOSED WIRES. IT APPEARS AS THOUGH THE CORD WAS INTENTIONALLY CUT, AND THE CUSTOMER WAS APPROACHED WITH REGARD TO CONFIRMING THIS ASSERTION. THEY HAVE NOT PROVIDED ANY FURTHER INFORMATION REGARDING 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)'. INTERNAL REFERENCE: (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6696372 ↗
• InjuryJul 7, 2017Maintenance Does Not Comply To Manufacturers Recommendations; Maintenance Does Not Comply To Manufacturers Recommendations

  IT WAS REPORTED BY THE CAREGIVER THAT THE FILTER OF THIS DEVICE WAS VERY DIRTY AS THE PATIENT HAD NEVER CHANGED IT, AND AS A RESULT THE PATIENT WAS HOSPITALISED WITH WHAT THE CAREGIVER DESCRIBED AS 'BACTERIA BUILDUP'. IT ALSO SUBSEQUENTLY TRANSPIRED THAT THE NEBULISER CUPS AND MASKS HAD NOT BEEN BEING CLEANED REGULARLY - BUT REPLACED MONTHLY INSTEAD. THE IFU FOR THE COMPRESSOR STATES 'THE FILTER IS TO BE REPLACED WHEN IT APPEARS DISCOLORED OR WET' AND THE IFU FOR THE NEBULISER STATES 'AFTER EACH USE, DISCONNECT TUBING FROM SIDESTREAM AND WASH ALL PARTS SEPARATELY IN MILD LIQUID DETERGENT AND WARM WATER. RINSE THOROUGHLY AND SHAKE OUT EXCESS WATER. ALLOW TO AIR DRY AND REASSEMBLE.' REPLACEMENT FILTERS WERE PROVIDED, AND THE CLEANING REQUIREMENTS EXPLAINED TO THE CAREGIVER. THE PATIENT HAS RETAINED THE DEVICE, AND NO FURTHER ISSUES HAVE BEEN REPORTED WITH IT. (B)(4).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6692811 ↗
• MalfunctionJun 9, 2017Degraded; Degraded

  IT WAS REPORTED THAT THE POWER CORD OF THIS DEVICE WAS RIPPING AND FALLING APART. ON RETURN OF THE DEVICE FOR EVALUATION, IT WAS APPARENT THAT THE INSULATION ON THE MAINS CORD WAS DEGRADED TO THE EXTENT THAT BARE WIRES WERE VISIBLE. OUR EVALUATION CONCLUDED THAT IN ALL LIKELIHOOD THE CORD HAS BEEN SUBJECTED TO CONSIDERABLE EXTERNAL FORCE. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6629122 ↗