BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BITEPRO SOLO LARYNGOSCOPE

    MDR report key: 17424781 · Received July 28, 2023

    Report

    Report Number
    MW5120342
    Event Type
    Injury
    Date Received
    July 28, 2023
    Date of Event
    July 3, 2023
    Report Date
    July 25, 2023
    Manufacturer
    FLEXICARE MEDICAL LTD.
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PROVIDER DETERMINED INTUBATION WAS NECESSARY, AND THE BRITEPRO SOLO WAS RETRIEVED. UPON INTUBATION ATTEMPT, THE MAC 3 PRO BLADE BULB DID NOT ILLUMINATE. PROVIDER WAS FORCED TO RETRIEVE A SECOND LARYNGOSCOPE, RESULTING IN A DELAY OF CARE. UPON FURTHER INSPECTION, IT WAS DETERMINED THAT BULB FAILURE WAS CAUSED BY A POOR SOLDER JOINT IN THE HANDLE, ON A PLATE CONNECTING THE BATTERIES AND BULB. REFER TO ADDITIONAL DOCUMENTS IN I2K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157752 BITEPRO SOLO LARYNGOSCOPE LARYNGOSCOPE, RIGID CCW FLEXICARE MEDICAL LTD. 040310

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention