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

Model Number	NOXBOX-I
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2026
Type of Reportable Event	Death
Event or Problem Description
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.
Additional Manufacturer Narrative
The device was disassembled by the hospital after the event.The relationship of the reported issue to the patient's outcome cannot be established at this time.The incident is still under investigation.Per 21 c.F.R.803.16, a report or other information submitted by a reporting entity under this part, and any release by fda of that report or information, does not reflect a conclusion by the party submitting the report or by fda that the report or information constitutes an admission that the device or the reporting entity, caused or contributed to the reportable event.

• 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: 50274567
• Report Number: 3012796317-2026-00047
• Device Sequence Number: 18786207
• Product Code: MRN
• UDI-Device Identifier: 05060541640009
• UDI-Public: (01)05060541640009
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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): 08/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NOXBOX-I
• Device Catalogue Number: REQNOXBOX-I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Nitric Oxide
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown