BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOMIMED

    MDR report key: 9210498 · Received October 18, 2019

    Report

    Report Number
    3003213883-2019-00001
    Event Type
    Malfunction
    Date Received
    October 18, 2019
    Date of Event
    September 20, 2019
    Report Date
    November 22, 2019
    Manufacturer
    BOMIMED
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON PRELIMINARY REVIEW OF THE IMAGES PROVIDED, BOMIMED SUSPECTS THE BLADE TO BE MISSING THE LIGHT ROD WHICH TRANSMITS THE LIGHT TO THE TIP OF THE BLADE. BOMIMED IS WAITING TO HEAR FROM THE CUSTOMER TO CONFIRM IF THE LIGHT ROD WAS COMPLETELY MISSING OR FELL OUT OF THE BLADE AND WAS IN THE PRODUCTS PEEL POUCH PACKAGING.

    Description of Event or Problem · 0

    THE BLADE WAS PULLED TO BE USED IN A CODE BLUE AND IT HAD NO LIGHT SOURCE WHEN PULLED FOR USE.

    Additional Manufacturer Narrative · 1

    UPON PRELIMINARY REVIEW OF THE IMAGES PROVIDED, BOMIMED SUSPECTS THE BLADE TO BE MISSING THE LIGHT ROD WHICH TRANSMITS THE LIGHT TO THE TIP OF THE BLADE. BOMIMED IS WAITING TO HEAR FROM THE CUSTOMER TO CONFIRM IF THE LIGHT ROD WAS COMPLETELY MISSING OR FELL OUT OF THE BLADE AND WAS IN THE PRODUCTS PEEL POUCH PACKAGING.

    Description of Event or Problem · 1

    THE BLADE WAS PULLED TO BE USED IN A CODE BLUE AND IT HAD NO LIGHT SOURCE WHEN PULLED FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005840 BOMIMED LARYNGOSCOPE BLADE CCW BOMIMED MAC 4 4717

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention