BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AERIS

    MDR report key: 5369279 · Received January 15, 2016

    Report

    Report Number
    5369279
    Event Type
    Malfunction
    Date Received
    January 15, 2016
    Date of Event
    January 12, 2016
    Report Date
    January 14, 2016
    Manufacturer
    BRYAN MEDICAL, INC
    Product Code
    EOQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN 8MM BALLOON DILATOR WAS BEING USED IN THE AIRWAY DURING A DML/BRONCH (DIRECT MICROLARYNGOSCOPY) PROCEDURE. THE BALLOON WAS INFLATED USING A PRESSURE REGULATED BALLOON DILATION SYRINGE AND PLACED IN THE PATIENT FOR DILATION. ONCE INFLATED, THE BALLOON WOULD NOT DEFLATE WITH THE SYRINGE AND HAD TO BE CUT WITH A KNIFE TO BE REMOVED FROM THE PATIENT. THE MAX PRESSURE IN THE BALLOON DID NOT EXCEED 17ATM, AS STATED BY THE MANUFACTURER AS THE MAX PRESSURE THE BALLOON CAN WITHSTAND. A 7MM BALLOON WAS THEN USED WITH THE SAME SYRINGE WITH NO MALFUNCTION. THE PATIENT WAS NOT HARMED. MANUFACTURER RESPONSE FOR BALLOON DILATOR, BRYAN (PER SITE REPORTER): MANUFACTURER WISHES TO TEST IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30155 AERIS BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BRYAN MEDICAL, INC 22457133F

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR