BEUDAMED
    FDA Adverse Event Death Summary report: N

    GALAXY SYSTEM

    MDR report key: 22922563 · Received August 29, 2025

    Report

    Report Number
    3021325287-2025-00027
    Event Type
    Death
    Date Received
    August 29, 2025
    Date of Event
    July 30, 2025
    Report Date
    August 29, 2025
    Manufacturer
    NOAH MEDICAL CORP.
    Product Code
    EOQ
    UDI-DI
    00850048825048
    PMA / PMN Number
    K223144
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2222563 GALAXY SYSTEM GALAXY SYSTEM EOQ NOAH MEDICAL CORP. 00850048825048

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Hospitalization| O| R| D