BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOMIMED

    MDR report key: 6708818 · Received July 12, 2017

    Report

    Report Number
    3003213883-2017-00003
    Event Type
    Malfunction
    Date Received
    July 12, 2017
    Date of Event
    May 15, 2017
    Report Date
    July 5, 2017
    Manufacturer
    BOMIMED INC
    Product Code
    CCW
    Removal / Correction Number
    9071838-07/13/17-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    PUT BATTERIES INTO LARYNGOSCOPE HANDLE, LIGHT WAS CHECKED BY PRESSING DOWN ON THE BULB AND WAS WORKING PROPERLY. BEGAN TO FLICKER DURING INTUBATION. PATIENT WAS SUCCESSFULLY INTUBATED WITH A GLIDESCOPE WITH NO DIFFICULTY.

    Description of Event or Problem · 1

    PUT BATTERIES INTO LARYNGOSCOPE HANDLE, LIGHT WAS CHECKED BY PRESSING DOWN ON THE BULB AND WAS WORKING PROPERLY. BEGAN TO FLICKER DURING INTUBATION. PATIENT WAS SUCCESSFULLY INTUBATED WITH A GLIDESCOPE WITH NO DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488958 BOMIMED LARYNGOSCOPE HANDLE CCW BOMIMED INC OL-334L6 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention