NOxBOXi NOXBOX-IRecalls & reported problems

Summary

The FDA's MAUDE database contains 121 adverse event reports that list this exact device (DI 05060541640016), received between Feb 20, 2020 and Sep 22, 2026 — classified as 5 deaths, 32 injuries, 84 malfunctions.

The most frequently reported specific device problem is “Gas Output Problem” (52 reports).

6 FDA recall records name this device's identifier, 5 still open.

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.

Recalls naming this device

1. Sep 14, 2026Open, Classified

   Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.

   Z-3306-2026 · Root cause: Component design/selection · FDA record ↗

2. Aug 19, 2026Open, Classified

   Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.

   Z-3165-2026 · Root cause: Device Design · FDA record ↗

3. Sep 9, 2025Open, Classified

   The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts.

   Z-0029-2026 · Root cause: Software design · FDA record ↗

4. Sep 9, 2025Open, Classified

   Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz).

   Z-0028-2026 · Root cause: Software design · FDA record ↗

5. Jul 19, 2023Open, Classified

   Replacement of the internal Sample Pump due to high failure rates.

   Z-2544-2025 · Root cause: Component design/selection · FDA record ↗

6. May 3, 2023Terminated

   Device may experience malfunctions due to misalignment of the check valve in the manifold. If the device fails, there is a risk of nitric oxide leak, oxygen gas leak, or earlier cylinder gas changeover than expected or not at all. In a worst case scenario, there may be an interruption in therapy which could lead to oxygen desaturation of the patient and associated complications.

   Z-1667-2023 · Root cause: Component change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 121 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Inappropriate or Unexpected Reset; Application Program Freezes or Fails to Launch

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860187 ↗
• DeathAug 17, 2026Unexpected Shutdown

  NOxBOX Ltd. became aware, through (E1), of an adverse event that occurred outside the United States involving a NOxBOXi nitric oxide delivery system.According to the reporter, during inhaled nitric oxide (iNO) therapy the device unexpectedly powered off. The reporter stated that, although the device was connected to an external power source, the external power indicator was not illuminated and the device could not be powered back on. The device's external power supply was subsequently exchanged.Following the event, the device was opened and inspected by unauthorized hospital personnel. The reporter stated that a burning odor was observed originating from the power supply unit (PSU) board.The reporter further stated that the patient expired following the event. At the time of this report, the relationship between the reported device issue and the patient's outcome has not been established.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50274567 ↗
• InjuryJun 29, 2026Gas Output Problem

  (E1) REPORTED THAT WHILE DELIVERING INHALED NITRIC OXIDE (INO) THERAPY TO AN ADULT PATIENT USING THE (D4) DEVICE, THE DEVICE UNEXPECTEDLY STOPPED DELIVERING INO TO THE PATIENT. ACCORDING TO THE HOSPITAL REPORT, THE PATIENT'S SPO2 AND BLOOD PRESSURE DETERIORATED WHILE CONNECTED TO THE VENTILATOR AND THE (D4) DEVICE. THE DEVICE WAS SUBSEQUENTLY REMOVED FROM SERVICE AND EXCHANGED FOR ANOTHER UNIT, AFTER WHICH THE REPORTED ISSUE WAS RESOLVED. FOLLOWING THE INTERVENTION, THE PATIENT'S VITAL SIGNS RETURNED TO PRE-EVENT LEVELS. NO LASTING ADVERSE EFFECTS OR SUSTAINED CHANGES IN THE PATIENT'S CLINICAL STATUS WERE REPORTED. VENTILATOR MODE AND SETTINGS: SERVO-U.

  Patient problems: Low Blood Pressure/ Hypotension; Low Oxygen Saturation

  MAUDE report 25659748 ↗
• MalfunctionJun 24, 2026Gas Output Problem; Device-Device Incompatibility

  (E1) REPORTED THAT WHILE DELIVERING INHALED NITRIC OXIDE (INO) THERAPY TO A 24-WEEK GESTATIONAL AGE NEONATAL PATIENT USING THE (D4) DEVICE, FLUCTUATIONS IN THE MONITORED NITRIC OXIDE CONCENTRATION WERE OBSERVED. THE DEVICE WAS BEING USED IN CONJUNCTION WITH A BUNNELL LIFEPULSE JET VENTILATOR (MODEL 203/204). ACCORDING TO THE HOSPITAL REPORT, THE NITRIC OXIDE DOSE WAS SET TO 20 PPM AND THE MONITORED CONCENTRATION FLUCTUATED APPROXIMATELY BETWEEN 16 PPM AND 30 PPM. THE PATIENT WAS REPORTED TO BE CLINICALLY UNSTABLE, REQUIRING 80-100% FIO2 AND EXPERIENCING FREQUENT DESATURATION EVENTS UNRELATED TO THE PERFORMANCE OF THE DEVICE. HOSPITAL STAFF PERFORMED EXTENSIVE TROUBLESHOOTING, INCLUDING REPOSITIONING THE SAMPLE LINE CLOSER TO THE PATIENT WHICH RESULTED IN AN OBSERVED IMPROVEMENT IN DOSE STABILITY. HOSPITAL CLINICIANS NOTED THAT THE FLUCTUATIONS APPEARED TO CORRELATE WITH EPISODES OF PATIENT AGITATION AND VENTILATOR ALARMS AND EXPRESSED THE OPINION THAT THE OBSERVED FLUCTUATIONS WERE LIKELY RELATED TO THE PATIENT'S CONDITION RATHER THAN A MALFUNCTION OF THE DEVICE. NO PATIENT HARM OR LASTING ADVERSE EFFECTS WERE REPORTED. VENTILATOR MODE AND SETTINGS: BUNNELL LIFEPULSE JET VENTILATOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25607673 ↗
• InjuryJun 23, 2026Gas Output Problem

  (E1) REPORTED THAT WHILE DELIVERING INHALED NITRIC OXIDE (INO) THERAPY TO AN ADULT PATIENT USING THE (D4) DEVICE, THE DEVICE UNEXPECTEDLY STOPPED DELIVERING INO TO THE PATIENT. ACCORDING TO THE HOSPITAL REPORT, THE PATIENT'S SPO2 AND BLOOD PRESSURE DETERIORATED WHILE CONNECTED TO THE VENTILATOR AND THE (D4) DEVICE. THE DEVICE WAS SUBSEQUENTLY REMOVED FROM SERVICE AND EXCHANGED FOR ANOTHER UNIT, AFTER WHICH THE REPORTED ISSUE WAS RESOLVED. FOLLOWING THE INTERVENTION, THE PATIENT'S VITAL SIGNS RETURNED TO PRE-EVENT LEVELS. NO LASTING ADVERSE EFFECTS OR SUSTAINED CHANGES IN THE PATIENT'S CLINICAL STATUS WERE REPORTED. VENTILATOR MODE AND SETTINGS: SERVO-U. PER 21 CFR 803.16, A REPORT OR OTHER INFORMATION SUBMITTED BY A REPORTING ENTITY UNDER THIS PART, AND ANY RELEASE REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION BY THE PARTY SUBMITTING THE REPORT OR BY FDA THAT THE REPORT OR CONSTITUTES AN ADMISSION THAT THE DEVICE OR THE REPORTING ENTITY, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

  Patient problems: Low Blood Pressure/ Hypotension; Low Oxygen Saturation

  MAUDE report 25594073 ↗
• MalfunctionJun 8, 2026Device Sensing Problem

  E1: REPORTED THAT WHILE DELIVERING INHALED NITRIC OXIDE (INO) THERAPY TO A PATIENT USING THE D4 DEVICE, THE DEVICE FAILED TO ACCURATELY MONITOR THE NITRIC OXIDE CONCENTRATION AT THERAPY INITIATION. ACCORDING TO THE HOSPITAL REPORT, THE MONITORED NITRIC OXIDE CONCENTRATION DID NOT CORRESPOND TO THE TARGET DOSE SETTING AT THE START OF THERAPY. IN RESPONSE, THE DEVICE WAS REMOVED FROM SERVICE AND REPLACED WITH A BACKUP UNIT, AFTER WHICH INO THERAPY CONTINUED WITHOUT FURTHER ISSUE. FOLLOWING REMOVAL FROM THE PATIENT, THE DEVICE GENERATED AN INTERNAL FAULT ALARM. NO PATIENT HARM OR LASTING ADVERSE EFFECTS WERE REPORTED. VENTILATOR MODE AND SETTINGS: ECMO MACHINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428152 ↗
• MalfunctionJun 5, 2026Gas Output Problem

  (E1) REPORTED THAT WHILE DELIVERING INHALED NITRIC OXIDE (INO) THERAPY TO A NEONATAL PATIENT USING THE (D4) DEVICE, DOSE FLUCTUATIONS WERE OBSERVED. ACCORDING TO THE HOSPITAL REPORT, THE MONITORED DOSE FLUCTUATED FROM APPROXIMATELY 1-30 PPM AROUND A TARGET DOSE OF 20 PPM. HOSPITAL STAFF PERFORMED TROUBLESHOOTING AT THE BEDSIDE AND ULTIMATELY EXCHANGED THE DEVICE WITH A BACKUP UNIT. NO PATIENT HARM OR LASTING ADVERSE EFFECTS WERE REPORTED. VENTILATOR MODE AND SETTINGS: SERVO-U; SIMV PRVC; RATE 15 VT 12, PSV 6.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25410496 ↗
• MalfunctionMay 29, 2026Gas Output Problem

  (E1) REPORTED THAT WHILE DELIVERING INHALED NITRIC OXIDE (INO) THERAPY TO A NEONATAL PATIENT USING THE (D4) DEVICE, MINOR FLUCTUATIONS IN THE MONITORED NO CONCENTRATION OF APPROXIMATELY 5PPM WERE OBSERVED. HOSPITAL STAFF PERFORMED TROUBLESHOOTING AT THE BEDSIDE AND ULTIMATELY EXCHANGED THE DEVICE WITH A BACKUP UNIT. NO PATIENT HARM OR LASTING ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337145 ↗
• MalfunctionMay 27, 2026Device-Device Incompatibility

  (E1) REPORTED THAT WHILE DELIVERING INHALED NITRIC OXIDE (INO) THERAPY TO A NEONATAL PATIENT USING THE (D4) DEVICE, FLUCTUATIONS IN THE DELIVERED NITRIC OXIDE CONCENTRATION WERE OBSERVED. THE DEVICE WAS BEING USED IN CONJUNCTION WITH A BUNNELL LIFEPULSE JET VENTILATOR (MODEL 203/204). ACCORDING TO THE HOSPITAL REPORT, THE MONITORED NITRIC OXIDE CONCENTRATION FLUCTUATED BETWEEN APPROXIMATELY 5 PPM AND 25 PPM AROUND A TARGET DOSE OF 20 PPM. HOSPITAL STAFF PERFORMED TROUBLESHOOTING AT THE BEDSIDE AND ULTIMATELY EXCHANGED THE DEVICE WITH A BACKUP UNIT. NO PATIENT HARM OR LASTING ADVERSE EFFECTS WERE REPORTED. VENTILATOR MODE AND SETTINGS: BUNNELL LIFEPULSE JET VENTILATOR (MODEL 203/204): PIP 25, RATE 420, PEEP 10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25301538 ↗
• MalfunctionApr 27, 2026Device Sensing Problem

  (E)(1) REPORTED THAT WHILE DELIVERING INHALED NITRIC OXIDE (INO) THERAPY TO AN ADULT PATIENT USING THE (D)(4) DEVICE, INACCURATE MONITORED GAS VALUES WERE OBSERVED. ACCORDING TO THE HOSPITAL REPORT, THE PATIENT BEGAN TO DECOMPENSATE WHILE CONNECTED TO THE VENTILATOR AND THE (D)(4) DEVICE. IN RESPONSE, HOSPITAL STAFF MANUALLY VENTILATED THE PATIENT. THE DEVICE WAS SUBSEQUENTLY REMOVED FROM THE PATIENT AND EXCHANGED FOR ANOTHER UNIT, AFTER WHICH THE ISSUES WERE RESOLVED. FOLLOWING REMOVAL FROM THE PATIENT, THE DEVICE FAILED TO PASS A SENSOR ZERO CALIBRATION. AFTER THESE INTERVENTIONS, THE PATIENT'S VITAL SIGNS RETURNED TO PRE-EVENT LEVELS. NO LASTING ADVERSE EFFECTS OR SUSTAINED CHANGES IN THE PATIENT'S CLINICAL STATUS WERE REPORTED. VENTILATOR MODE AND SETTINGS: SERVO-U; VOLUME CONTROL RATE 20 / VT 460 / PEEP +12 / 60%. PER 21 C.F.R. 803.16, A REPORT OR OTHER INFORMATION SUBMITTED BY A REPORTING ENTITY UNDER THIS PART, AND ANY RELEASE REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION BY THE PARTY SUBMITTING THE REPORT OR BY FDA THAT THE REPORT OR CONSTITUTES AN ADMISSION THAT THE DEVICE OR THE REPORTING ENTITY, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 24998283 ↗
• InjuryApr 27, 2026Device Sensing Problem

  (E)(1) REPORTED THAT WHILE DELIVERING INHALED NITRIC OXIDE (INO) THERAPY TO AN ADULT PATIENT USING THE (D)(4) DEVICE, INACCURATE MONITORED GAS VALUES WERE OBSERVED. ACCORDING TO THE HOSPITAL REPORT, THE PATIENT BEGAN TO DECOMPENSATE WHILE CONNECTED TO THE VENTILATOR AND THE (D)(4) DEVICE. IN RESPONSE, HOSPITAL STAFF MANUALLY VENTILATED THE PATIENT. THE DEVICE WAS SUBSEQUENTLY REMOVED FROM THE PATIENT AND EXCHANGED FOR ANOTHER UNIT, AFTER WHICH THE ISSUES WERE RESOLVED. FOLLOWING REMOVAL FROM THE PATIENT, THE DEVICE FAILED TO PASS A SENSOR ZERO CALIBRATION. AFTER THESE INTERVENTIONS, THE PATIENT'S VITAL SIGNS RETURNED TO PRE-EVENT LEVELS. NO LASTING ADVERSE EFFECTS OR SUSTAINED CHANGES IN THE PATIENT'S CLINICAL STATUS WERE REPORTED. VENTILATOR MODE AND SETTINGS: SERVO-U; VOLUME CONTROL RATE 20 / VT 460 / PEEP +12 / 60% PER 21 C.F.R. 803.16, A REPORT OR OTHER INFORMATION SUBMITTED BY A REPORTING ENTITY UNDER THIS PART, AND ANY RELEASE REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION BY THE PARTY SUBMITTING THE REPORT OR BY FDA THAT THE REPORT OR CONSTITUTES AN ADMISSION THAT THE DEVICE OR THE REPORTING ENTITY, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 24998279 ↗
• MalfunctionApr 27, 2026Gas Output Problem

  (E)(1) REPORTED THAT WHILE DELIVERING INHALED NITRIC OXIDE (INO) THERAPY TO A PEDIATRIC PATIENT USING THE (D)(4) DEVICE, FLUCTUATIONS IN THE MONITORED NITRIC OXIDE CONCENTRATION WERE OBSERVED. THE HOSPITAL STAFF RESPONDED BY TROUBLESHOOTING AND ULTIMATELY EXCHANGING THE AFFECTED DEVICE WITH A BACKUP UNIT. NO PATIENT HARM OR LASTING ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24998270 ↗
• MalfunctionApr 23, 2026Gas Output Problem

  (E)(1) REPORTED THAT WHILE DELIVERING INHALED NITRIC OXIDE (INO) THERAPY TO AN NEONATAL PATIENT USING THE (D)(4) DEVICE, FLUCTUATIONS IN THE MONITORED NO CONCENTRATION WERE OBSERVED. THE DEVICE WAS SUBSEQUENTLY REMOVED FROM THE PATIENT AND EXCHANGED FOR ANOTHER UNIT, AFTER WHICH THE DOSING ISSUES WERE RESOLVED. NO HARM TO THE PATIENT OR SUSTAINED CHANGES IN THE PATIENT'S CLINICAL STATUS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968169 ↗
• MalfunctionApr 22, 2026Gas Output Problem

  (E1) REPORTED THAT WHILE DELIVERING INHALED NITRIC OXIDE (INO) THERAPY TO A NEONATAL PATIENT USING THE (D4) DEVICE, FLUCTUATIONS IN THE MONITORED NITRIC OXIDE CONCENTRATION WERE OBSERVED. ACCORDING TO THE HOSPITAL REPORT, THE DISPLAYED NITRIC OXIDE CONCENTRATION FLUCTUATED BETWEEN APPROXIMATELY 0-40 PPM ON A TARGET DOSE OF 20 PPM. THE HOSPITAL STAFF RESPONDED BY EXCHANGING THE AFFECTED DEVICE WITH A BACKUP UNIT. NO PATIENT HARM OR LASTING ADVERSE EFFECTS WERE REPORTED. VENTILATOR MODE AND SUPPORT: SERVO-U; SIMV PC 26/+6, R38, 100% FIO2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24959797 ↗
• MalfunctionApr 22, 2026Display Difficult to Read

  (E1) REPORTED THAT WHILE DELIVERING INHALED NITRIC OXIDE (INO) THERAPY TO A PEDIATRIC PATIENT USING THE (D)(4) DEVICE, INTERMITTENT VISUAL DISPLAY ABNORMALITIES WERE OBSERVED DURING THERAPY. NO PATIENT HARM OR LASTING ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24959782 ↗
• MalfunctionApr 22, 2026Gas Output Problem

  (E)(1) REPORTED THAT WHILE DELIVERING INHALED NITRIC OXIDE (INO) THERAPY TO A PEDIATRIC PATIENT USING THE (D)(4) DEVICE, THE MONITORED NITRIC OXIDE CONCENTRATION EXCEEDED THE TARGET DOSE. ACCORDING TO THE HOSPITAL REPORT, THE TARGET DOSE WAS SET AT 1 PPM, AND THE MONITORED CONCENTRATION WAS APPROXIMATELY 3 PPM. AT THE TIME OF THE EVENT, THE PATIENT WAS UNDERGOING WEANING FROM NITRIC OXIDE THERAPY. THE WEANING PROTOCOL WAS CONTINUED, AND THE DEVICE WAS REMOVED FROM THE PATIENT UPON COMPLETION. NO HARM TO THE PATIENT OR SUSTAINED CHANGES IN THE PATIENT'S CLINICAL STATUS WERE REPORTED. VENTILATOR MODE AND SETTINGS: SERVO-U; RATE 24, INSP PRESSURE 24, PEEP 6, PRESSURE SUPPORT 16.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953643 ↗
• MalfunctionApr 14, 2026Gas Output Problem

  (E1) REPORTED THAT WHILE DELIVERING INHALED NITRIC OXIDE (INO) THERAPY TO AN ADULT PATIENT USING THE (D4) DEVICE, FLUCTUATIONS IN THE MONITORED NO CONCENTRATION WERE OBSERVED. ACCORDING TO THE HOSPITAL REPORT, TROUBLESHOOTING WAS PERFORMED; HOWEVER, THE FLUCTUATIONS DID NOT RESOLVE. THE DEVICE WAS SUBSEQUENTLY REMOVED FROM THE PATIENT AND EXCHANGED FOR ANOTHER UNIT, AFTER WHICH THE DOSING ISSUES WERE RESOLVED. NO HARM TO THE PATIENT OR SUSTAINED CHANGES IN THE PATIENT'S CLINICAL STATUS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24871798 ↗
• InjuryApr 3, 2026Obstruction of Flow

  (E1) REPORTED THAT FLUCTUATIONS IN THE MONITORED NITRIC OXIDE (NO) CONCENTRATION WERE OBSERVED WHILE DELIVERING INHALED NITRIC OXIDE (INO) THERAPY TO A NEONATAL PATIENT USING THE (D4) DEVICE. ACCORDING TO THE HOSPITAL REPORT, THE SAMPLE POINT ADAPTER WAS POSITIONED IN CLOSE PROXIMITY TO A HUMIDIFIER, RESULTING IN WATER ENTERING THE SAMPLING CIRCUIT. HOSPITAL STAFF REPORTED THAT WATER WAS PRESENT THROUGHOUT THE SAMPLING CIRCUIT. A TRANSIENT DECREASE IN OXYGEN SATURATION WAS OBSERVED DURING THE EVENT. FOLLOWING REPLACEMENT OF THE DEVICE, THE PATIENT'S VITAL SIGNS RETURNED TO PRE-EVENT LEVELS. NO LASTING ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24775196 ↗
• MalfunctionMar 30, 2026Device-Device Incompatibility

  (E1) REPORTED THAT WHILE DELIVERING INHALED NITRIC OXIDE (INO) THERAPY TO A NEONATAL PATIENT USING THE (D4) DEVICE, FLUCTUATIONS IN THE DELIVERED NITRIC OXIDE CONCENTRATION WERE OBSERVED. THE DEVICE WAS BEING USED IN CONJUNCTION WITH A BUNNELL LIFEPULSE JET VENTILATOR (MODEL 203/204). ACCORDING TO THE HOSPITAL REPORT, THE MONITORED DOSE FLUCTUATED FROM APPROXIMATELY 15-25 PPM AROUND A TARGET DOSE OF 20 PPM. HOSPITAL STAFF ELECTED TO CONTINUE THERAPY USING THE SAME DEVICE. NO PATIENT HARM OR LASTING ADVERSE EFFECTS WERE REPORTED. VENTILATOR MODE AND SETTINGS: BUNNELL LIFEPULSE JET VENTILATOR (MODEL 203/204): PIP 14, R 300, PEEP 6.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24731740 ↗
• MalfunctionMar 30, 2026Gas Output Problem

  (E1) REPORTED THAT WHILE DELIVERING INHALED NITRIC OXIDE (INO) THERAPY TO A NEONATAL PATIENT USING THE (D4) DEVICE, FLUCTUATIONS IN THE MONITORED NITRIC OXIDE CONCENTRATION WERE OBSERVED. ACCORDING TO THE HOSPITAL REPORT, THE DISPLAYED NITRIC OXIDE CONCENTRATION FLUCTUATED BETWEEN APPROXIMATELY 0-45 PPM ON A TARGET DOSE OF 20 PPM. NO PATIENT HARM OR LASTING ADVERSE EFFECTS WERE REPORTED. VENTILATOR MODE AND SUPPORT: ANESTHESIA MACHINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729573 ↗
• MalfunctionMar 24, 2026Gas Output Problem

  (E1) REPORTED THAT WHILE DELIVERING INHALED NITRIC OXIDE (INO) THERAPY TO A NEONATAL PATIENT USING THE (D4) DEVICE, THE DEVICE ALARMED FOR A CRITICAL DELIVERY FAULT. THE HOSPITAL STAFF RESPONDED BY EXCHANGING THE AFFECTED DEVICE WITH A BACKUP UNIT. NO PATIENT HARM OR LASTING ADVERSE EFFECTS WERE REPORTED. VENTILATOR MODE AND SETTINGS: HFOV 3100A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24680593 ↗
• MalfunctionMar 24, 2026Gas Output Problem

  (E1) REPORTED THAT WHILE DELIVERING INHALED NITRIC OXIDE (INO) THERAPY TO A NEONATAL PATIENT USING THE (D4) DEVICE, FLUCTUATIONS IN THE MONITORED NITRIC OXIDE CONCENTRATION WERE OBSERVED. ACCORDING TO THE HOSPITAL REPORT, THE DISPLAYED NITRIC OXIDE CONCENTRATION FLUCTUATED BETWEEN APPROXIMATELY 0-20 PPM ON A TARGET DOSE OF 20 PPM. THE HOSPITAL STAFF RESPONDED BY EXCHANGING THE AFFECTED DEVICE WITH A BACKUP UNIT. NO PATIENT HARM OR LASTING ADVERSE EFFECTS WERE REPORTED. VENTILATOR MODE AND SUPPORT: HFOV; HZ 12, AMP, 35, MAP 15, O2 80%.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674021 ↗
• MalfunctionMar 24, 2026Gas Output Problem

  (E1) REPORTED THAT FLUCTUATIONS IN THE MONITORED NITRIC OXIDE CONCENTRATION WERE OBSERVED WHILE DELIVERING INHALED NITRIC OXIDE (INO) THERAPY TO A NEONATAL PATIENT USING THE (D4) DEVICE. ACCORDING TO THE HOSPITAL REPORT, FOLLOWING A CHANGE IN THE TARGET DOSE FROM 20 PPM TO 15 PPM, THE MONITORED NITRIC OXIDE CONCENTRATION FLUCTUATED BETWEEN APPROXIMATELY 9 PPM AND 35 PPM. NO PATIENT HARM OR LASTING ADVERSE EFFECTS WERE REPORTED. VENTILATOR MODE AND SETTINGS: SERVO-U; PC RATE 30, PIP 25, PEEP 5, 32%, MVE 1.8 ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674020 ↗
• MalfunctionMar 23, 2026Inappropriate or Unexpected Reset; Application Program Freezes or Fails to Launch

  (E1) REPORTED THAT WHILE DELIVERING INHALED NITRIC OXIDE (INO) THERAPY USING THE (D4) DEVICE TO AN PEDIATRIC PATIENT A PRODUCT PROBLEM OCCURRED WHERE THE DEVICE ALARMED FOR AN INTERNAL FAULT/SYSTEM DIAGNOSTICS AND PROMPTED THE HOSPITAL STAFF TO RESTART THE DEVICE. THE HOSPITAL STAFF RESPONDED BY EXCHANGING THE AFFECTED DEVICE WITH A BACKUP UNIT. NO PATIENT HARM OR LASTING ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662599 ↗
• MalfunctionMar 19, 2026Gas Output Problem

  (E1) REPORTED THAT FLUCTUATIONS IN THE MONITORED NITRIC OXIDE CONCENTRATION WERE OBSERVED WHILE DELIVERING INHALED NITRIC OXIDE (INO) THERAPY TO A NEONATAL PATIENT USING THE (D4) DEVICE. ACCORDING TO THE HOSPITAL REPORT, THE MONITORED NITRIC OXIDE CONCENTRATION FLUCTUATED BETWEEN APPROXIMATELY 12 PPM AND 34 PPM AROUND A TARGET DOSE OF 20 PPM. THE HOSPITAL REPORTED THAT THE FLUCTUATIONS BEGAN AFTER THE PATIENT WAS TRANSITIONED FROM HIGH-FREQUENCY OSCILLATORY VENTILATION (HFOV) TO A SERVO-U CONVENTIONAL VENTILATOR. NO PATIENT HARM OR LASTING ADVERSE EFFECTS WERE REPORTED. VENTILATOR MODE AND SETTINGS: SERVO-U.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641071 ↗