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	Serious Injury
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
• MDR Report Key: 24998279
• Report Number: 3012160128-2026-00004
• Device Sequence Number: 9774011
• Product Code: MRN
• UDI-Device Identifier: 05060541640009
• UDI-Public: (01)05060541640009
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2026
• Report Date (Section F): 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/16/2026
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2026
• 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: NOXIVENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/24/2026