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 Codes	Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)
Date of Event	05/21/2026
Type of Reportable Event	Serious Injury
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 performed in accordance with approved service and test procedures.Upon arrival, the device met all manufacturer specifications for nitric oxide delivery, monitoring performance, and overall functionality.No faults or out-of-specification conditions were identified during the evaluation.As part of the investigation, the device log file was reviewed.The log data indicated that the first alarm generated during the reported event was a vent flow idle alarm, followed by a decrease in the sample pump count.These findings are consistent with the introduction of a leak into the ventilator circuit.Depending on the location of the leak, dilution of the sampled gas may occur, resulting in a decrease in the monitored nitric oxide concentration consistent with the reported event.Based on the available information, the investigation did not identify evidence of a device malfunction or manufacturing defect.The device log data are most consistent with a condition external to the device, such as a leak introduced into the ventilator circuit during use.However, the available information is insufficient to definitively determine the root cause of the reported event.A review of complaint history for this failure mode indicated that the occurrence rate remains within established control limits.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.
Event or Problem Description
(e1) reported that while delivering inhaled nitric oxide (ino) therapy to an adult patient using the (d4) device, the device unexpectedly stopped delivering ino to the patient.According to the hospital report, the patient's spo2 and blood pressure deteriorated while connected to the ventilator and the (d4) device.The device was subsequently removed from service and exchanged for another unit, after which the reported issue was resolved.Following the intervention, 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.

• 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: 25659748
• Report Number: 3012796317-2026-00043
• Device Sequence Number: 5764745
• Product Code: MRN
• UDI-Device Identifier: 05060541640009
• UDI-Public: (01)05060541640009
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 06/29/2026

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: 06/01/2026
• Initial Report FDA Received Date: 06/29/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOXIVENT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown