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

Model Number	NOXBOX-I
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	03/02/2026
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 receipt at the service center, the device was observed to be contaminated with liquid within the sampling pathway.According to the instructions for use (ifu, section 6-1), the sample point adapter should be connected approximately 30 cm behind the patient y-piece on the inspiratory limb.This placement is intended to provide sufficient distance from the humidifier to minimize the potential for water entering the sampling circuit.Based on the device evaluation and review of the available information, the event consistent with use conditions that are not aligned with the ifu.No device malfunction was identified that would have contributed to the reported event.A review of complaint history for this failure mode indicated that the occurrence rate remains within established control limits.
Event or Problem Description
(e1) reported that fluctuations in the monitored nitric oxide (no) concentration were observed while delivering inhaled nitric oxide (ino) therapy to a neonatal patient using the (d4) device.According to the hospital report, the sample point adapter was positioned in close proximity to a humidifier, resulting in water entering the sampling circuit.Hospital staff reported that water was present throughout the sampling circuit.A transient decrease in oxygen saturation was observed during the event.Following replacement of the device, the patient's vital signs returned to pre-event levels.No lasting adverse effects were reported.

• 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: 24775196
• Report Number: 3012796317-2026-00030
• Device Sequence Number: 12278247
• Product Code: MRN
• UDI-Device Identifier: 05060541640009
• UDI-Public: (01)05060541640009
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/01/2026

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: 03/06/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male