BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH PLATFORM

    MDR report key: 16130809 · Received January 10, 2023

    Report

    Report Number
    3014447948-2023-00002
    Event Type
    Malfunction
    Date Received
    January 10, 2023
    Date of Event
    January 4, 2023
    Report Date
    February 16, 2023
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    EOQ
    UDI-DI
    B634MON0000060
    PMA / PMN Number
    K211493
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ENGINEERING CONFIRMED THAT THE LOGS OF THE REPORTED EVENT WERE NOT BEING UPLOADED TO THE CLOUD. THREE GOOD FAITH EFFORTS (GFE) WERE MADE ACQUIRING THE LOGS. HOWEVER, THE LOGS HAVE NOT BECOME AVAILABLE AS OF 2/15/2023 (SEE SUPPORT REQUEST 00062784). DUE TO THE ABSENCE OF LOGS, ENGINEERING IS UNABLE TO CONFIRM THE OCCURRENCE OF THIS FAULT AND A FULL FAILURE ANALYSIS CANNOT BE PERFORMED. THE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. AS THE FAILURE CANNOT BE CONFIRMED AND NO ROOT CAUSE CAN BE IDENTIFIED, THIS RECORD CANNOT BE LINKED TO ANY EXISTING MODEFS OR FMEA LINE ITEMS RELATED TO THE REPORTED ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THERE ARE NO REPORTS OF NONCONFORMANCE THAT RELATE TO THE REPORTED INCIDENT. A REVIEW FOR SIMILAR COMPLAINT SHOWS THE REPORTED ISSUE IS A KNOWN ISSUE HOWEVER THE ROOT CAUSE IS SPECIFIC TO EACH INDIVIDUAL CASE. THE SCOPE IN THE CASE WERE EXAMINED AND A REVIEW OF THE CALIBRATION DATA OBTAINED FROM PRODUCTION FINAL ACCEPTANCE TESTING REVEALED ALL ACCEPTANCE CRITERIA WERE MET AND NO ANOMALIES FOUND. BASED ON THE RESULTS FROM THE EXAMINATION, THE PRODUCT MET SPECIFICATIONS. A REVIEW OF SIMILAR INVESTIGATIONS WITH SIMILAR REPORTED ISSUE (EM ERROR) HAS NOTED THAT THIS IS A KNOWN ISSUE AND HAVE NOT ESTABLISHED A POSSIBLE ROOT CAUSE. THIS ISSUE WILL BE TRACKED AND TRENDED IN THE MONTHLY COMPLAINT TREND REVIEW MEETINGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE, THE PHYSICIAN REPORTED ENCOUNTERING A 1205-50-0 NAVIGATION FAULT AND THE NAVIGATION WAS INACCURATE. AS THE SCOPE WAS MOVED, THE DISTANCE TO THE TARGET WOULD NOT CHANGE. THE PHYSICIAN CHOSE 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
    260585 MONARCH PLATFORM BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES EOQ AURIS HEALTH, INC. MON-000006 B634MON0000060

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown