InnoSpire Essence 00 (REF 1100312)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00383730001821), received between Apr 27, 2017 and Nov 13, 2024 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (5 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2024Overheating of Device; Failure to Deliver; Overheating of Device; Failure to Deliver

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE DEVICE WILL NOT MIST OR PUSH OUT AIR. IT IS REPORTED THE SIDE OF THE DEVICE'S CASE LOOKS TO BE MELTED BUT NOT DISCOLORED. THE DEVICE WAS PLUGGED INTO THE WALL. 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 20674589 ↗
• MalfunctionMar 22, 2024Fire; Fire

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A ESSENCE WITH SSD & SSR DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED CORD CAUGHT ON FIRE AND BURNING SMELL WAS OBSERVED WITHIN THE DEVICE. THERE WAS NO REPORT 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 18964757 ↗
• MalfunctionOct 31, 2023Failure 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 AND ADVISED THE PATIENT TO REPLACE THE FILTER AND OTHER PARTS. ALSO, REVIEWED THE CLEANING 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 18038973 ↗
• MalfunctionOct 18, 2023Unexpected Shutdown; Unexpected Shutdown

  THE USER REPORTED THE DEVICE INNOSPIRE ESSENCE WITH THE ALLEGATION OF SHUTTING OFF. THE MANUFACTURER RECEIVED THE DEVICE FOR INVESTIGATION. THE TECHNICIAN CONFIRMS THE DEVICE NOT POWERING ON, DAMAGED POWER CORD. THEY FOUND MEDIUM AMOUNTS OF CONTAMINATION: DIRT, DUST, DEBRIS, AND HAIR INSIDE THE DEVICE. THE EVIDENCE OF DEVICE BEING USED WITHOUT NPC FILTER INSTALLED EVENTUALLY CONTAMINATES THROUGHOUT THE NPC FILTER PORT ON AND INSIDE THE MOTOR/PUMP. ALSO, A LOOSE ECCENTRIC SUBASSEMBLY OIL CAP HAS SEPARATED ENOUGH TO START LEAKING OIL. THERE WAS NO PATIENT HARM OR INJURY. THE MANUFACTURER CONCLUDES THAT NO FURTHER ACTION IS NECESSARY AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17959267 ↗
• MalfunctionOct 11, 2023Contamination; Mechanical Problem; Contamination; Mechanical Problem

  THE MANUFACTURER BECAME AWARE OF A USER OF AN ESSENCE NEBULIZER ALLEGING THAT THE DEVICE HAS A WEAK COMPRESSOR AND IS NOT DISPENSING ANY RX. THERE WAS NO REPORT OF SERIOUS HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE, THE MANUFACTURER CONFIRMED THAT THE MOTOR WAS WEAK, FAULTY (NO AEROSOL) AND NOT DISPENSING THE MEDICATION. THERE WAS ALSO CONTAMINATION, WHITE POWDER LIKE TALC LIKE SUBSTANCE DUE TO CUSTOMER MISUSE. THE UNIT WAS SCRAPPED. THE MANUFACTURER CONCLUDES THAT THE COMPLAINT WAS CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17910409 ↗
• MalfunctionOct 11, 2023Crack; Crack

  THE MANUFACTURER BECAME AWARE OF A USER OF AN ESSENCE NEBULIZER ALLEGING THAT THE COVER ON THE COMPRESSOR WAS CRACKED AND THE USER WAS CONCERNED THAT IT MAY BE AFFECTING THE OUTPUT OF THEIR MEDICATION. THERE WAS NO REPORT OF SERIOUS HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR FURTHER EVALUATION. DURING THE EVALUATION OF THE DEVICE THE MANUFACTURER CONFIRMED THAT THE TOP ENCLOSURE OF THE COMPRESSOR WAS CRACKED, AND OUTLET TUBE WAS CRACKED AFFECTING OUTPUT OF MEDICATION. THE UNIT WAS SCRAPPED. THE MANUFACTURER CONCLUDES THAT THE COMPLAINT WAS CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17909942 ↗
• MalfunctionSep 25, 2023Melted; Overheating of Device; Smoking; Melted; Overheating of Device; Smoking

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF A THERMAL EVENT. THE USER REPORTED SMOKE AND OVERHEATING OF THE DEVICE CAUSING THE DEVICE TO MELT. AN ODOR WAS ALSO OBSERVED. THE MANUFACTURER RECEIVED THE DEVICE FOR INVESTIGATION. THE TECHNICIAN CONFIRMS HEAVY SIGNS OF THERMAL DAMAGE, AS WELL AS A DIRTY NPC FILTER. THE TECHNICIAN CONFIRMS THERE WAS A THERMAL EVENT THAT MELTED/WARPED THE PLASTIC. THERE WAS MUCH DEBRIS, DIRT, DUST FOUND ONCE THE DEVICE WAS BROKEN DOWN. THE TECHNICIAN FOUND NO EVIDENCE OF THERMAL EVENTS SUCH AS SMOKE, WIRES MELTING, OR OTHER RELATED ELECTRICAL FIRE EVIDENCE. HEAVY RUST WAS FOUND SHOWING A DAMP ENVIRONMENT. THE TECHNICIAN DETERMINED THAT USE OF THE DEVICE WITH DIRTY FILTERS FOR SO LONG CONTAMINATES THROUGHOUT THE NPC FILTER PORT, THEN INSIDE THE MOTOR PUMP CAUSING FAILURES. THE EXACT CAUSE OF THE THERMAL EVENT COULD NOT BE CONFIRMED. THERE WAS NO PATIENT HARM OR INJURY. THE MANUFACTURER CONCLUDES THAT NO FURTHER ACTION IS NECESSARY AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17805484 ↗
• MalfunctionAug 31, 2022Electrical /Electronic Property Problem; Melted; Electrical /Electronic Property Problem; Melted

  THE MANUFACTURER RECEIVED AN ALLEGATION THAT THE BOTTOM OF THE CASE IS MELTED AND THERE IS OPENINGS AT THE BOTTOM OF AN ESSENCE NEBULIZER. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE MANUFACTURER RECEIVED THE DEVICE FOR INVESTIGATION. THE TECHNICIAN CONFIRMS THE INITIAL ALLEGATIONS OF THE CASE IS MELTED AT THE BOTTOM AND THERE ARE OPENINGS WHERE THE ENCLOSURES SHOULD MEET AT THE BOTTOM OF THE DEVICE. THE TECHNICIAN CONFIRMS THERE WAS A THERMAL EVENT THAT MELTED/WARPED THE BOTTOM OF THE COMPRESSOR. THE FILTER FOR THE NEBULIZER WAS MISSING. THE UNIT WILL NOT POWER ON WHEN AC POWER WAS INTRODUCTED TO THE DEVICE. THE MOTOR DOES SPIN BUT IS STIFFER THAN NORMAL. IT APPEARS THE SAFETY FUSE HAS BLOWN PREVENTING AN ELECTRICAL THERMAL EVENT. THE DEVICE DID EXPERIENCE SOME SORT OF THERMAL EVENT, SEIZING THE MOTOR AND MELTING THE ENCLOSURE. THE EXACT CAUSE OF THE THERMAL EVENT COULD NOT 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 TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15328960 ↗
• MalfunctionAug 8, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER BECAME AWARE OF A FINDING OF EXPOSED WIRES ON AN INNOSPIRE ESSENCE NEBULIZER DURING EVALUATION. THE ORIGINAL ALLEGATIONS WERE RUNNING LOUD AND CORD WHERE IT CONNECTS IS UNRAVELLED. THERE WAS NO PATIENT HARM OR INJURY. THE MANUFACTURER RECEIVED THE DEVICE AND COULD NOT CONFIRM THE COMPLAINT OF RUNNING LOUD, THE UNIT HAD NO POWER. THERE WAS EXPOSED WIRES DUE TO THE AC WIRE BEING CUT. THERE WAS NO THERMAL DAMAGE, NO VOIDS TO THE ENCLOSURES. 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 BACK-UP DEVICE FOR RESPIRATORY DELIVERY IF THIS DEVICE IS NOT OPERABLE. THIS REPORT WILL BE FILED AS AN INITIAL-FINAL REPORT. BASED ON THE INFORMATION AVAILABLE, THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15182945 ↗
• MalfunctionMay 12, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED AN INNOSPIRE ESSENCE 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 ESSENCE 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 FAILURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14371548 ↗
• MalfunctionFeb 24, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION FROM A CUSTOMER THAT AN ESSENCE NEBULIZER HAD POWER ISSUES. THERE WAS NO REPORT OF HARM OR INJURY. THE MANUFACTURER RECEIVED THE DEVICE AND CONFIRMED THE COMPLAINT. THERE WAS PHYSICAL DAMAGE TO THE POWER CORD AND THE PRONG WAS BROKEN OFF. THERE WAS NO EVIDENCE OF THERMAL DAMAGE, NO EXPOSED WIRES. 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 BACK-UP DEVICE FOR RESPIRATORY DELIVERY IF THIS DEVICE IS NOT OPERABLE. BASED ON THE INFORMATION AVAILABLE, THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13591173 ↗
• MalfunctionFeb 22, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION FROM A USER OF AN ESSENCE NEBULIZER THAT THE PRONGS WERE SHEARED OFF IN THE POWER CORD. THERE WAS NO REPORT OF HARM OR INJURY. THE MANUFACTURER RECEIVED THE DEVICE AND CONFIRMED THAT THE PLUG ENDS WERE REMOVED. THERE WAS NO EVIDENCE OF THERMAL DAMAGE, NO EXPOSED WIRES. 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 BACK-UP DEVICE FOR RESPIRATORY DELIVERY IF THIS DEVICE IS NOT OPERABLE. BASED ON THE INFORMATION AVAILABLE, THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13577191 ↗
• MalfunctionMay 11, 2021Material Integrity Problem; Insufficient Device Problem Information; Material Integrity Problem; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED A COMPLAINT OF DEFECTIVE AC CORD WITH WIRES SHOWING ON A INNOSPIRE ESSENCE NEBULIZER. THERE WAS NO REPORTED PATIENT HARM OR INJURY. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED COMPLAINT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806668 ↗
• MalfunctionApr 12, 2021Degraded; Degraded

  THE MANUFACTURE RECEIVED THIS DEVICE FOR EVALUATION IN RESPONSE TO A REPORT OF A "BAD POWER CORD". ONE OF THE PRONGS HAS BROKEN OFF. THERE WAS NO PATIENT HARM OR INJURY. THE EXACT DATE OF THE REPORTED EVENT IS UNKNOWN. DURING THE EVALUATION, IT WAS NOTED THE POWER CORD WAS MISSING ON OF ITS PRONGS, EXPOSING THE USER TO A POSSIBLE SHOCK. THE ROOT CAUSE OF THE PHYSICAL DAMAGE IS UNKNOWN, HOWEVER IT IS LIKELY THE POWER CORD WAS 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 A PNEUMATIC (JET) NEBULIZER TO PRODUCE AEROSOL PARTICLES OF MEDICATION FOR RESPIRATORY THERAPY FOR CHILDREN AND ADULTS. 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 IS NOT LABELED FOR LIFE SUPPORT. THIS DEVICE MEETS ALL RELEVANT UL AND IEC STANDARDS. BASED ON THE INFORMATION AVAILABLE, THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NECESSARY, AND WILL CONTINUE TO MONITOR COMPLAINTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11648565 ↗
• MalfunctionFeb 15, 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 A THERMAL EVENT TO THE NEBULIZER'S AC POWER CORD. THERE WERE NO INITIAL REPORT OF EXPOSED WIRING. THERE WAS NO REPORT OF PATIENT HARM OR INJURY ASSOCIATED WITH THIS REPORTED EVENT. UPON RECEIPT OF THE DEVICE, THE MANUFACTURER NOTED WORN INSULATION DAMAGE TO THE POWER CORD NEAR THE REINFORCED INSULATION AT THE NEBULIZER, WITH EXPOSURE TO ELECTRICAL WIRES. THE EXPOSED WIRES ARE MELTED. 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. OPERATIONAL CHECKS ON THE NEBULIZER PASSED, NO PROBLEM FOUND. 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 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. DU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11329740 ↗
• MalfunctionApr 10, 2020Fire; Fire

  THE MANUFACTURER WAS MADE AWARE BY A DURABLE MEDICAL EQUIPMENT COMPANY 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 ACCIDENTALLY BEFORE HE WENT TO BED AND WAS LEFT RUNNING THROUGHOUT THE NIGHT WHILE HE WAS SLEEPING. THE USER WAS AWAKENED TO FIND THE DEVICE WAS ON FIRE WITH VISIBLE FLAMES INSIDE OF THE DEVICE AND MELTING HAD OCCURRED TO THE CASING OF THE DEVICE. THERE WERE ALSO EXPOSED WIRES VISIBLE INSIDE OF THE DEVICE DUE TO THE SEPARATION OF THE CASING. THE MANUFACTURER REQUESTED THE RETURN OF THE DEVICE FOR INVESTIGATION; HOWEVER, THE DURABLE MEDICAL EQUIPMENT COMPANY HAS DISPOSED OF THE DEVICE AND WILL NOT BE RETURNING IT TO THE MANUFACTURER. 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 INFORMATI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9948519 ↗
• MalfunctionJul 26, 2017Degraded; Degraded

  IT WAS REPORTED THAT THE CORD OF THIS DEVICE WAS SPLIT WHERE IT GOES INTO THE UNIT. 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 6743409 ↗
• MalfunctionApr 27, 2017Cut In Material; Cut In Material

  IT WAS REPORTED THAT THIS DEVICE HAD NO AIR FLOW. ON RECEIPT OF THE DEVICE FOR EVALUATION IT WAS OBSERVED THAT THE MAIN 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 INFORMATION REGARDING HOW THE DEVICE CAME TO BE IN THIS CONDITION, ONLY THAT IT WAS IN THIS CONDITION WHEN THEY RECEIVED IT FROM THEIR CUSTOMER. 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 6525677 ↗