BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY SYSTEM

    MDR report key: 18414386 · Received December 28, 2023

    Report

    Report Number
    3021325287-2023-00003
    Event Type
    Malfunction
    Date Received
    December 28, 2023
    Date of Event
    December 7, 2023
    Report Date
    December 25, 2023
    Manufacturer
    NOAH MEDICAL INC.
    Product Code
    EOQ
    UDI-DI
    00850048825048
    PMA / PMN Number
    K223144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING A NOAH GALAXY-ASSISTED BRONCHOSCOPY PROCEDURE ON (B)(6) 2023, A FLUOROSCOPY DELAY OF ABOUT 15 SECONDS WAS REPORTED BY THE USER. WHILE THERE WAS A FLUOROSCOPY DELAY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY HARM TO THE PATIENT. UPON INITIAL INVESTIGATION, A THOROUGH REVIEW OF MANUFACTURING RECORDS FOR THE UTILIZED GALAXY SYSTEM REVEALED NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED FLUOROSCOPY DELAY. NO MALFUNCTIONS WERE REPORTED FOR THE BRONCHOSCOPE USED DURING THE PROCEDURE.

    Description of Event or Problem · 0

    ON (B)(6) 2023, A CUSTOMER REPORTED A 15-SECOND FLUOROSCOPY DELAY DURING A GALAXY-ASSISTED BRONCHOSCOPY PROCEDURE. NEVERTHELESS, THE PHYSICIAN SUCCESSFULLY COMPLETED THE PROCEDURE WITHOUT ANY REPORTED HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1489411 GALAXY SYSTEM GALAXY SYSTEM EOQ NOAH MEDICAL INC. N/A N/A 00850048825048

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female