BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH PLATFORM

    MDR report key: 11889729 · Received May 26, 2021

    Report

    Report Number
    3014447948-2021-00015
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    April 27, 2021
    Report Date
    April 28, 2021
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    EOQ
    UDI-DI
    B634MON0000060
    PMA / PMN Number
    K193534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THERE WAS NO ALLEGATION OF DEVICE FAILURE. THE RISK OF PNEUMOTHORAX IS DOCUMENTED IN 105-000299-01 REV D, MONARCH BRONCH RISK MANAGEMENT REPORT. BASED ON THE INFORMATION AVAILABLE FOR THIS EVENT, THE ROOT CAUSE IS RELATED TO A KNOWN INHERENT RISK OF THE DEVICE AND PROCEDURE AS DOCUMENTED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE LOCATION WAS RIGHT UPPER LOBE. THE LOCATION OF THE PNEUMOTHORAX WAS RIGHT SIDE. DURING THE PROCEDURE THE PATIENT WENT IN CARDIAC ARREST FROM A TENSION PNEUMOTHORAX. A NEEDLE DECOMPRESSION WAS USED, AND PATIENT REGAINED THEIR PULSE. A CHEST TUBE WAS PLACED IN THE PATIENT AND THE PATIENT WAS HOSPITALIZED. THE CHEST TUBE WAS REMOVED ON (B)(6) 2021. THE PATIENT WAS DISCHARGED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782410 MONARCH PLATFORM BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES EOQ AURIS HEALTH, INC. MON-000006 B634MON0000060

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R