I neb 00Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00383730000909), received between Dec 27, 2023 and Jun 3, 2025 — classified as 3 deaths, 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A I-NEB DEVICE IS NOT WORKING. THE DEVICE IS NOT SIGNALING THE END OF THE TREATMENT AND THERE IS MEDICATION REMAINING THE DEVICE'S CHAMBER. THE PATIENT STATES THEY MISSED THEIR DOSES OF PROMIXIN OVER THE WEEKEND AND FEELS IT IS AFFECTING THEIR CHEST. THE PATIENT TRIED A REPLACEMENT CHAMBER, AND THE ISSUE HAS NOT RESOLVED. 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 22137282 ↗
• DeathMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF I-NEB CF UK UNIT ALLEGES DEATH - PATIENT NO LONGER USING INEB DEVICE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER¿S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21688986 ↗
• MalfunctionMar 14, 2025Restricted Flow rate; Restricted Flow rate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT THE PATIENT'S DEVICE IS SIGNALING THE END OF TREATMENT AFTER ONLY 2 BREATHS AND MOST OF THE MEDICATION IS REMAINING IN THE CHAMBER. AS RESULT, THE PATIENT REPORTED THAT HE IS MISSING SOME OF HIS DOSES AND IT WASN'T HAPPENING PREVIOUSLY. THE PATIENT REPORTED THAT IT WAS HAPPENING WITH ALL OF THE CHAMBERS, AND HE BELIEVES IT IS AN ISSUE WITH THE DEVICE. 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 21607871 ↗
• MalfunctionMar 14, 2025Restricted Flow rate; Restricted Flow rate

  THE MANUFACTURER RECEIVED INFORMATION FROM THE PATIENT'S REPRESENTATIVE ALLEGING THAT THAT HER DAUGHTER I-NEB IS NOT WORKING CORRECTLY. THE DEVICE DOES NOT SIGNAL THE END OF TREATMENT WITH ANY OF HER MEDICATIONS AND MEDICATION IS ALSO REMAINING IN THE CHAMBER. ADDITIONALLY, THE PATIENT'S MOTHER REPORTS THAT HER DAUGHTER HAS NOT BEEN RECEIVING A FULL DOSE OF PROMIXIN DUE THE ISSUES WITH THE DEVICE. 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 21607652 ↗
• MalfunctionFeb 5, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE MANUFACTURER WAS CONTACTED REGARDING AN I-NEB CF UK UNIT THAT IS NOT FUNCTIONING PROPERLY, WHICH IS AFFECTING THE PATIENT RECEIVING TREATMENT. THE PATIENT REPORTS THAT THE TREATMENT TAKES MORE THAN 10 MINUTES TO COMPLETE, AND THERE ARE TIMES WHEN IT DOES NOT FINISH AT ALL. THE PATIENT HAS MENTIONED THAT HE SOMETIMES GIVES UP BECAUSE THE TREATMENT TAKES TOO LONG. 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 21318539 ↗
• MalfunctionFeb 4, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE MANUFACTURER WAS CONTACTED REGARDING AN I-NEB CF UK UNIT, WHICH WAS NOT DELIVERING MEDICATION PROPERLY (NOT EMPTYING AND NOT TURNING OFF AGAIN). THE PATIENT STATES THAT THE DEVICE HAS NOT BEEN OPERATING PROPERLY SINCE THE DAY THEY STARTED USING IT. THERE ARE NO CLAIMS OF PATIENT HARM OR SERIOUS INJURY, AND NO MEDICAL INTERVENTION IS SPECIFIED. 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 21308030 ↗
• DeathJan 17, 2025Adverse 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 I-NEB CF UK UNIT. THE PATIENT HAS PASSED AWAY. 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 21180638 ↗
• InjuryJan 6, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT THE I-NEB DEVICE DISPLAYED AN ERROR CODE, ER66 WHEN IT WAS TURNED ON, PREVENTING THE DELIVERY OF MEDICATION. THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CHEST INFECTION. MEDICAL INTERVENTION WAS REQUIRED, LEADING TO HOSPITALIZATION AND THE ADMINISTRATION OF INTRAVENOUS (IV) ANTIBIOTICS. A REPLACEMENT DEVICE WAS SUBSEQUENTLY ISSUED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Unspecified Infection

  MAUDE report 21081569 ↗
• MalfunctionNov 4, 2024Unexpected Therapeutic Results; Unexpected Therapeutic Results

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO AN I-NEB CF DEVICE. THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE DEVICE WAS NOT CREATING ANY VAPOR AND MEDICATION REMAINING IN THE CHAMBER AFTER 10 MINUTES OF USE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE NORMALLY COMPLETES A TREATMENT WITHIN 3 TO 4 MINUTES. THE PATIENT HAS BEEN USING A DIFFERENT DEVICE TO COMPLETE TREATMENTS. 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 20599290 ↗
• MalfunctionNov 4, 2024Unexpected Therapeutic Results; Unexpected Therapeutic Results

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO AN I-NEB CF DEVICE. THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE PATIENT'S DEVICE SUDDENLY STOPPED VIBRATING AND WAS NOT ENDING/COMPLETING TREATMENT. THE MEDICATION REMAINED IN THE CENTER OF THE CHAMBER AFTER 20 MINUTES OR MORE OF USE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE PATIENT DOES NOT HAVE AN ALTERNATIVE WAY OF RECEIVING TREATMENT RESULTING IN MISSED DOSES. 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 20599074 ↗
• MalfunctionNov 4, 2024Unexpected Therapeutic Results; Unexpected Therapeutic Results

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO AN I-NEB CF DEVICE. THE MANUFACTURER RECEIVED INFORMATION ALLEGING TREATMENT TIMES WITH THE NEBULIZER HAVE BEEN PROLONGED, AND THE DEVICE DID NOT SIGNAL THE END OF TREATMENT. THE REPORTER ADDITIONALLY STATED SOME MEDICATION REMAINED IN THE CENTER OF THE CHAMBER, BUT THE REPORTER WAS NOT 100% SURE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE PATIENT WAS CLEANING THE DEVICE CORRECTLY AND WAS AN EXPERIENCED I-NEB USER. 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 20598878 ↗
• MalfunctionOct 10, 2024Inaccurate Delivery; Inaccurate Delivery

  THE MANUFACTURER WAS CONTACTED REGARDING AN I-NEB DEVICE WITH AN ALLEGATION THAT THE PATIENT DID NOT RECEIVE THE FULL DOSE. THERE ARE NO ALLEGATIONS OF PATIENT HARM OR SERIOUS INJURY, AND NO MEDICAL INTERVENTION HAS BEEN SPECIFIED. 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 20414084 ↗
• MalfunctionOct 9, 2024Inaccurate Delivery; Inaccurate Delivery

  THE MANUFACTURER WAS CONTACTED REGARDING AN I-NEB DEVICE DUE TO COMPLAINTS THAT THE DEVICE WOULD STOP AND SIGNAL THE END OF TREATMENT, WITH THE MEDICATION DISAPPEARING FROM THE CHAMBER AFTER 5 MINUTES OF TREATMENT. THERE IS NO ALLEGATION OF PATIENT HARM OR SERIOUS INJURY. NO MEDICAL INTERVENTION HAS BEEN SPECIFIED. 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 20411701 ↗
• DeathJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING TO AN ISSUE RELATED TO I-NEB CF. THE PATIENT WAS DIED. THE DEVICE WAS RETURNED TO MANUFACTURER FOR EVALUATION, TECHNICIAN CONFIRMED THAT THE DEVICE VISUALLY LOOKED FINE. TREATMENTS WERE FINISHING IN FULL. THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19832436 ↗
• MalfunctionDec 27, 2023Overheating of Device; Failure to Shut Off; Overheating of Device; Failure to Shut Off

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A FAULTY I-NEBULIZER EVENT OCCURRED. THE PATIENT STATES THE DEVICE WOULD NOT END TREATMENT AND THAT THE DEVICE WAS HEATING UP. THE PATIENT CONFIRMED THAT THEY WERE NOT RECEIVING THEIR FULL PROMIXIN DOSE. THERE WAS NO HARM OR INJURY REPORTED. 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 18397054 ↗