BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BITEPRO OMNI

    MDR report key: 19761573 · Received July 17, 2024

    Report

    Report Number
    3006061749-2024-00027
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    June 17, 2024
    Report Date
    July 17, 2024
    Manufacturer
    FLEXICARE MEDICAL LTD
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EVENT AS DESCRIBED BY COMPLAINANT: EUGENE INSERTED LMA AND COULD NOT PROPERLY VENTILATE. HE PULLED OUT LMA, AND WENT TO DIRECTLY INTUBATE WITH A MILLER 3 BP OMNI. WHEN HE WENT TO APPLY PRESSURE ON THE BLADE TO VIEW THE VOCAL CORDS, THE LIGHT WENT OUT. HE BLINDLY INTUBATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2144193 BITEPRO OMNI LARYNGOSCOPE CCW FLEXICARE MEDICAL LTD 040-04-0430U 230500671

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown