MAUDE Adverse Event Report: NOxBOX Ltd NOxBOXi Nitric Oxide delivery system

Model Number	NOXBOX-I
Medical Device Problem Codes	Inappropriate or Unexpected Reset (2959); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2026
Type of Reportable Event	Malfunction

• Brand Name: NOxBOXi Nitric Oxide delivery system
• Common Device Name: NOxBOXi
• Manufacturer (Section D): NOxBOX Ltd; 1 eurolink gateway; castle road; sittingbourne, 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: 50860187
• Report Number: 3012796317-2026-00056
• Device Sequence Number: 10053308
• Product Code: MRN
• UDI-Device Identifier: 05060541640009
• UDI-Public: (01)05060541640009
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Distributor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown