BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH PLATFORM

    MDR report key: 20028259 · Received August 22, 2024

    Report

    Report Number
    3014447948-2024-00018
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 23, 2024
    Report Date
    August 20, 2024
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    EOQ
    UDI-DI
    B634MON0000060
    PMA / PMN Number
    K231473
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS THAT THE SYSTEM WAS SHUT DOWN AND RESTARTED DUE TO AN INSTRUMENT STILL LOADED FAULT. THE LOG REVIEW INVESTIGATION AND CASE VIDEO CONFIRMED THE SYSTEM REPORTED THE INSTRUMENT STILL LOADED FAULT. THE INSTRUMENT STILL LOADED FAULT IS AN EXPECTED SYSTEM BEHAVIOR FOLLOWING A MAJOR FAULT. IN THIS CASE, THE MAJOR FAULTS WERE THE ETHERCAT FAILURE. ETHERCAT CABLE OF THE UMBILICAL CABLE THAT CONNECTS TO THE TOWER POWER BOX WAS SHAKEN, THE ETHERCAT COMMUNICATION DROPPED. THIS FAULT IS THROWN WHEN A MAJOR FAULT RECOVERY IS ATTEMPTED WITHOUT UNLOADING OF THE INSTRUMENTS. TO CLEAR THE FAULT, THE USER IS INSTRUCTED TO LOAD/UNLOAD THE INSTRUMENTS AND THEN PROCEED TO CLEAR THE FAULT. THE ETHERCAT FAILURE WAS TRACED TO DEFORMATION ON THE ETHERCAT CABLE OF THE UMBILICAL CABLE THAT DOES NOT ALLOW THE CONNECTOR TO SECURELY ATTACH TO THE TOWER BOX AND MAKE FULL CONTACT. THE ROOT CAUSE IS TRACED TO COMPONENT FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THAT DURING THE MONARCH BRONCHOSCOPY PROCEDURE, THE PHYSICIAN HAD TO SHUT DOWN AND RESTART THE SYSTEM DUE TO AN ENCOUNTERED ISSUE. PHYSICIAN ELECTED TO ABORT THE PROCEDURE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SYSTEM ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1986252 MONARCH PLATFORM BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES EOQ AURIS HEALTH, INC. MON-000006 B634MON0000060

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other