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

Model Number	NOXBOX-I
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to the u.S.Service center for evaluation and underwent a comprehensive functional inspection and performance verification.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.As part of the investigation, the device log file was reviewed.The log data indicated fluctuations consistent with the hospital's report.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 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.

• 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: 25301538
• Report Number: 3012796317-2026-00038
• Device Sequence Number: 13087991
• Product Code: MRN
• UDI-Device Identifier: 05060541640009
• UDI-Public: (01)05060541640009
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 05/27/2026

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: 05/15/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2021
• 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: 8 MO
• Patient Sex: Female