BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOMIMED

    MDR report key: 9241914 · Received October 25, 2019

    Report

    Report Number
    3003213883-2019-00002
    Event Type
    Malfunction
    Date Received
    October 25, 2019
    Date of Event
    August 25, 2019
    Report Date
    November 22, 2019
    Manufacturer
    BOMIMED
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 0

    DURING AN INTUBATION ATTEMPT,THE LARYNGOSCOPE HANDLE ILLUMINATION FAILED AFTER INSERTING THE BLADE INTO THE MOUTH AND ATTEMPTING TO LIFT THE TONGUE AND MANDIBLE. THE LAMP WAS ILLUMINATED WHEN THE BLADE WAS ATTACHED TO THE HANDLE AND LOCKED FULLY OPEN, BUT TURNED OFF WITH THE DOWNWARD PRESSURE ON THE BLADE DURING THE LIFT. RELEASING PRESSURE RESULTED IN ILLUMINATION COMING BACK ON. THE BLADE WAS REMOVED AND REATTACHED TO THE HANDLE WITH THE SAME RESULT.

    Description of Event or Problem · 1

    DURING AN INTUBATION ATTEMPT,THE LARYNGOSCOPE HANDLE ILLUMINATION FAILED AFTER INSERTING THE BLADE INTO THE MOUTH AND ATTEMPTING TO LIFT THE TONGUE AND MANDIBLE. THE LAMP WAS ILLUMINATED WHEN THE BLADE WAS ATTACHED TO THE HANDLE AND LOCKED FULLY OPEN, BUT TURNED OFF WITH THE DOWNWARD PRESSURE ON THE BLADE DURING THE LIFT. RELEASING PRESSURE RESULTED IN ILLUMINATION COMING BACK ON. THE BLADE WAS REMOVED AND REATTACHED TO THE HANDLE WITH THE SAME RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037547 BOMIMED LARYNGOSCOPE BLADE CCW BOMIMED DISPOSABLE MEDIUM 5218

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention