MAUDE Adverse Event Report: NOAH MEDICAL CORP. GALAXY SYSTEM

Catalog Number	CRB-1550
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Pneumothorax (2012)
Date of Event	07/30/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
On (b)(6) 2025, a bronchoscopy procedure was performed using the noah galaxy device, and no device-related issues were reported during the case.The procedure was completed successfully, and the patient was discharged.Immediate post-procedure x-ray showed no evidence of pneumothorax.Approximately three hours later, the patient returned with respiratory distress and subsequently experienced cardiac arrest.A pneumothorax was identified, and the patient was admitted and was treated with targeted temperature management.The physician did not attribute these serious adverse events to the galaxy device.A clinical engineer conducted a log review, which did not reveal any device-related malfunctions or user errors.On august 4, 2025, the company representative was notified that the patient had passed away.The physician attributed the cause of death to bilateral pneumothorax resulting from the thymectomy and confirmed that the galaxy device was not considered a contributing factor.
Event or Problem Description
A galaxy-assisted bronchoscopy procedure was performed on a patient with no device-related malfunctions observed.The patient was discharged the same day; however, approximately three hours later, the patient returned with respiratory distress, experienced cardiac arrest, and was found to have a pneumothorax.The physician did not attribute these events to the use of the galaxy device.On august 4, 2025, the company representative was informed that the patient had unfortunately passed away.The physician attributed the cause of death to bilateral pneumothorax resulting from the thymectomy and confirmed that the galaxy device was not considered a contributing factor.

• Brand Name: GALAXY SYSTEM
• Common Device Name: GALAXY SYSTEM
• Manufacturer (Section D): NOAH MEDICAL CORP.; 2075 zanker road; san jose CA 95131
• Manufacturer (Section G): NOAH MEDICAL CORP; 2075 zanker road; san jose CA 95131
• Manufacturer Contact: patricia apps ; 2075 zanker road; san jose, CA 95131
• MDR Report Key: 22922563
• Report Number: 3021325287-2025-00027
• Device Sequence Number: 9156610
• Product Code: EOQ
• UDI-Device Identifier: 00850048825048
• UDI-Public: 010085004882504811240702
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K223144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2025

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 Catalogue Number: CRB-1550
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention; Death
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 51 KG
• Patient Ethnicity: Non Hispanic