BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH PLATFORM

    MDR report key: 15361952 · Received September 6, 2022

    Report

    Report Number
    3014447948-2022-00027
    Event Type
    Injury
    Date Received
    September 6, 2022
    Date of Event
    August 18, 2022
    Report Date
    October 13, 2022
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    EOQ
    UDI-DI
    B634MON0000060
    PMA / PMN Number
    K211493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THERE WERE NO DEVICE MALFUNCTIONS REPORTED FROM THE PROCEDURE. NO FURTHER INVESTIGATION WAS PERFORMED AS THERE IS INDICATION THAT THE REPORTED EVENT WAS NOT DUE TO DEVICE MALFUNCTION AND ALSO IT HAS BEEN STATED THAT THERE ARE NO ALLEGATIONS TOWARDS THE MONARCH. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SYSTEM 120137 AND THERE WERE NO NON- CONFORMANCES RELATED TO THE REPORTED INCIDENT IN THIS CASE. G4: 510(K) K211493.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO A MONARCH BRONCHOSCOPY PROCEDURE, THE ANESTHESIOLOGIST NOTED THAT THE PATIENT¿S BLOOD PRESSURE WAS ELEVATED. ONCE THE PATIENT¿S BLOOD PRESSURE WAS UNDER CONTROL, THE PHYSICIAN BEGAN THE BIOPSY. DURING THE PROCEDURE THE ANESTHESIOLOGIST NOTED THE PATIENT WAS NOT DOING WELL AND THE PATIENT WENT INTO CARDIAC ARREST. THE PHYSICIAN PERFORMED AN EMERGENT CONVERSION AND ABORTED THE CASE. THE PATIENT WAS INTUBATED. ON (B)(6) 2022 THE PHYSICIAN REPORTED 3 X-RAYS WERE TAKEN AND THERE WAS NO SIGN OF A PNEUMOTHORAX. THE PATIENT HAS RECOVERED. THERE WERE NO ISSUES OR FAULTS WERE REPORTED FROM THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2368011 MONARCH PLATFORM BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES EOQ AURIS HEALTH, INC. MON-000006 B634MON0000060

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H