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

Model Number	NOXBOX-I
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2026
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 that the majority of recorded nitric oxide concentration readings during the reported timeframe were within the device's allowable delivery accuracy specification (±20% of the target dose).The servo-u ventilator, in neonatal configuration, operates with a bias flow of 0.5 l/min ±8% which may fall below the stated operating range of the noxboxi device as indicated in the ifu.Under these neonatal ventilation conditions, the likelihood of transient variability in measured nitric oxide concentration is increased potentially impacting dose delivery.Should additional relevant information become available following completion of the investigation, a supplemental report will be submitted as required.
Event or Problem Description
(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.

• 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: 24641071
• Report Number: 3012796317-2026-00023
• Device Sequence Number: 18591242
• Product Code: MRN
• UDI-Device Identifier: 05060541640009
• UDI-Public: (01)05060541640009
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

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: 02/20/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOXIVENT.
• Patient Age: 5 MO
• Patient Sex: Male