BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH PLATFORM

    MDR report key: 18284343 · Received December 7, 2023

    Report

    Report Number
    3014447948-2023-00031
    Event Type
    Injury
    Date Received
    December 7, 2023
    Date of Event
    November 10, 2023
    Report Date
    January 3, 2024
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    EOQ
    PMA / PMN Number
    K211493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE SYSTEM LOGS WAS UNABLE TO CONFIRM THE OCCURRENCE OF ANY FAULTS OR ERRORS RELATED TO THE REPORTED ISSUE. SOURCE: S3: 2023-11-10/SYSTEM120106/{42EC9157-4BFA-4FE7-92CE-E6FEA63DBBDC}. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE SYSTEM; THERE WERE NO NON-CONFORMANCES RELATED TO THE ADVERSE EVENT. BASED ON THE INFORMATION AVAILABLE FOR THIS COMPLAINT, THE ROOT CAUSE OF THE REPORTED EVENT WAS IDENTIFIED TO BE AN ADVERSE EVENT RELATED TO PATIENT CONDITION.

    Additional Manufacturer Narrative · 0

    IN A FOLLOW UP CALL THE RESPIRATORY THERAPIST INFORMED THE ACCOUNT MANAGER THAT THE PATIENT HAD PASSED 3-DAYS AFTER THE PROCEDURE. THE RASPATORY THERAPIST REAFFIRMED THE MONARCH SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE PATIENTS DECREASE IN HR OR SUBSEQUENT DEATH. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY AURIS HEALTH, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, AURIS HEALTH, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN WAS ADJUSTING THE SCOPE TOWARDS TARGET OF NODULE AND THE PATIENTS HEART RATE (HR) BEGAN TO DECLINE AND THE PHYSICIAN ABORTED THE CASE. THE PATIENT THEN WENT INTO ASYSTOLE AND REQUIRED EMERGENT CONVERSION AND CHEST COMPRESSIONS. ONCE THE PATIENT REGAINED A PULSE THE WERE TRANSPORTED THE INTENSIVE CARE UNIT (ICU) WHERE THE PATIENT CODED AGAIN AND WAS BEING SENT TO THE CARDIAC CATH LAB. THE PHYSICIAN STATED THAT THE ADVERSE EVENTS ARE NOT ATTRIBUTED TO THE MONARCH SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1366268 MONARCH PLATFORM BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES EOQ AURIS HEALTH, INC. MON-000006

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other