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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
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 performed in accordance with approved service and test procedures.During the investigation, the internal sample pump was identified as the likely cause of the reported issue.The sample pump was replaced, and the device subsequently underwent post repair functional and performance testing.Following replacement of the sample pump, the device met all manufacturer specifications for nitric oxide delivery accuracy, gas monitoring performance, alarm functionality, and overall system operation.A review of complaint history for this failure mode determined that the occurrence rate remains within established control limits.
Event or Problem Description
E1: reported that while delivering inhaled nitric oxide (ino) therapy to a patient using the d4 device, the device failed to accurately monitor the nitric oxide concentration at therapy initiation.According to the hospital report, the monitored nitric oxide concentration did not correspond to the target dose setting at the start of therapy.In response, the device was removed from service and replaced with a backup unit, after which ino therapy continued without further issue.Following removal from the patient, the device generated an internal fault alarm.No patient harm or lasting adverse effects were reported.Ventilator mode and settings: ecmo machine.

• 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: 25428152
• Report Number: 3012796317-2026-00041
• Device Sequence Number: 18689453
• Product Code: MRN
• UDI-Device Identifier: 05060541640009
• UDI-Public: (01)05060541640009
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 05/01/2026
• Initial Report FDA Received Date: 06/08/2026
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOXIVENT
• Patient Sex: Unknown