MAUDE Adverse Event Report: NOXBOX LTD NOXBOXI NITRIC OXIDE DELIVERY SYSTEM

Model Number	NOXBOX-I
Medical Device Problem Codes	Gas Output Problem (1266); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was investigated onsite at the hospital.All testing was conducted in accordance with established service and test procedures.Gas-delivery accuracy, monitoring performance, and all other functional checks were confirmed to be within specification.Review of the event details indicated that the patient was a critically ill premature neonate and experiencing significant clinical instability.The reported fluctuations were observed to correlate with episodes of patient agitation and ventilator alarms, and improvement was reported following repositioning of the sampling line closer to the patient.Based on the available information, the observed fluctuations were determined to be primarily attributable to patient related factors present during treatment.Dose fluctuations occurring when the device is used in conjunction with the bunnell lifepulse jet ventilator are known to arise under low total volumetric flow conditions, depending on ventilator settings and patient characteristics.This failure mode has been previously identified by the manufacturer and is being addressed as part of an ongoing field correction and removal reported to the fda.
Event or Problem Description
(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 (model 203/204): pip 39, rate 300, i-time 0.26, 75% o2.Servo pressure 3.0.

• Brand Name: NOXBOXI NITRIC OXIDE DELIVERY SYSTEM
• Common Device Name: NOXBOXI
• Manufacturer (Section D): NOXBOX LTD; 1 eurolink gateway; castle road; sirringbourne, kent ME103 AG; UK ME103AG
• Manufacturer (Section G): NOXBOX LTD; 1 eurolink gateway; castle road; sittingbourne, kent ME10 3AG; UK ME10 3AG
• Manufacturer Contact: karen ring ; 1 eurolink gateway; castle road; sittingbourne, kent ME103-AG ; UK ME103AG
• MDR Report Key: 25607673
• Report Number: 3012796317-2026-00042
• Device Sequence Number: 5357973
• Product Code: MRN
• UDI-Device Identifier: 05060541640009
• UDI-Public: (01)05060541640009
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K233251
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NOXBOX-I
• Device Catalogue Number: REQNOXBOX-I
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOXIVENT.
• Patient Age: 5 MO
• Patient Sex: Unknown