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

Model Number	NOXBOX-I
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	04/03/2026
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.As part of the investigation, the device log file was reviewed.The log data indicated that inhaled nitric oxide (ino) delivery remained consistent with the set target and was not interrupted during the reported event.No impact to ino delivery was able to be established.However, oxygen concentration readings showed period erratic values and a failure of the sensor zero calibration associated with the oxygen sensor.Based on the device evaluation and review of the available information, by replacing the oxygen sensor the issue was resolved.Following repair, the device underwent post-repair functional testing and was confirmed to meet all manufacturer specifications for nitric oxide delivery, gas monitoring, and overall system performance prior to release.A review of complaint history for this failure mode indicated that the occurrence rate remains within established control limits.
Event or Problem Description
(e)(1) reported that while delivering inhaled nitric oxide (ino) therapy to an adult patient using the (d)(4) device, inaccurate monitored gas values were observed.According to the hospital report, the patient began to decompensate while connected to the ventilator and the (d)(4) device.In response, hospital staff manually ventilated the patient.The device was subsequently removed from the patient and exchanged for another unit, after which the issues were resolved.Following removal from the patient, the device failed to pass a sensor zero calibration.After these interventions, the patient's vital signs returned to pre-event levels.No lasting adverse effects or sustained changes in the patient's clinical status were reported.Ventilator mode and settings: servo-u; volume control rate 20 / vt 460 / peep +12 / 60%.Per 21 c.F.R.803.16, a report or other information submitted by a reporting entity under this part, and any release report or information, does not reflect a conclusion by the party submitting the report or by fda that the report or 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; 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: 24998283
• Report Number: 3012796317-2026-00036
• Device Sequence Number: 9774014
• Product Code: MRN
• UDI-Device Identifier: 05060541640009
• UDI-Public: (01)05060541640009
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 04/24/2026

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2020
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown