BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOMIMED DISPOSABLE MEDIUM LED LARYNGOSCOPE HANDLE

    MDR report key: 15628265 · Received October 18, 2022

    Report

    Report Number
    3003213883-2022-00001
    Event Type
    Malfunction
    Date Received
    October 18, 2022
    Date of Event
    June 4, 2022
    Report Date
    October 17, 2022
    Manufacturer
    BOMIMED INC
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE OCCURRENCE INVOLVED A BOMIMED HANDLE AND A BLADE FROM A DIFFERENT COMPANY, WHICH IS NOT CONTROLLED BY BOMIMED. THE DEVICES WERE BOTH DISPOSED OF AND NOT RETURNED, THEREFORE UNABLE TO COMPLETE AN INVESTIGATION AND DETERMINE A ROOT CAUSE.

    Description of Event or Problem · 0

    RELATING TO THE FAILURE OF THE LARYNGOSCOPE BLADE TO REMAIN ATTACHED TO THE LARYNGOSCOPE HANDLE. ATTEMPTING TO PERFORM DIRECT LARYNGOSCOPY, THE LARYNGOSCOPE BLADE WAS CLICKED ON TO THE HANDLE IN THE DOWN, STANDBY POSITION. WHEN BROUGHT UP TO CLICK INTO THE HANDLE AND ENGAGE THE LIGHT FOR USE, THE BLADE WOULD SLIDE OUT AND POP OFF THE HANDLE. THIS HAPPENED MORE THAN THREE TIMES WHEN ATTEMPTING TO USE THE DEVICE. THE SOLUTION WAS TO ATTACH THE HANDLE BETWEEN 45 AND 90 DEGREES, THEN MAINTAIN BACK PRESSURE WHEN SWINGING UP INTO PLACE. IT SEEMED THAT THE BUMPS USED TO LOCK THE BLADE IN TO PLACE, DISLODGED THE BLADE FORWARD OFF OF THE HANDLE IF BACK PRESSURE WAS NOT BEING APPLIED. THE ISSUE OCCURRED WHEN CHECKING THE DEVICE FOR USE BEFORE INTUBATION ATTEMPT, WHEN ATTEMPTING INTUBATION, AND ON THE SECOND INTUBATION ATTEMPT. THIS DID NOT GREATLY AFFECT PATIENT CARE, HOWEVER DID REQUIRE TWO DEDICATED HANDS TO KEEP THE DEVICE TOGETHER WHEN MOVING FROM STANDBY TO IN ACTION. ONCE THE BLADE WAS ENGAGED, THERE WERE NO PROBLEMS. THE AFFECTED DEVICES WERE DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2223279 BOMIMED DISPOSABLE MEDIUM LED LARYNGOSCOPE HANDLE DISPOSABLE MEDIUM LARYNGOSCOPE HANDLE CCW BOMIMED INC MEDIUM, LED UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention