BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOMIMED

    MDR report key: 7249380 · Received February 7, 2018

    Report

    Report Number
    3003213883-2018-00001
    Event Type
    Malfunction
    Date Received
    February 7, 2018
    Date of Event
    December 21, 2017
    Report Date
    February 7, 2018
    Manufacturer
    BOMIMED INC
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCTS WERE RETURNED TO BOMIMED FOR REVIEW. THE DEVICES WERE HEAVILY CONTAMINATED WITH BODILY FLUID, THEREFORE BOMIMED DID NOT OPEN THE PACKAGING. BOMIMED OBTAINED THE LOT NUMBER OF THE HANDLE ONLY AND HAVE COMPLETED A PRODUCT HISTORY REVIEW. THE HANDLE WAS FROM THE FIRST BATCH AFTER THE IMPLEMENTATION OF THE CONTACT DESIGN. FLICKERING MAY BE CAUSED BY VARIOUS ASPECTS FROM MECHANICAL CONNECTIONS TO ENVIRONMENTAL FACTORS, INCLUDING THE TYPE AND CHARGE THE BATTERIES CONTAIN. IT IS SUSPECTED AN UNSTABLE CONTACT WITH THE BATTERY MAY HAVE CAUSED THE FLICKERING, A RARE BUT KNOWN FACTOR IN WHICH IS CONTINUALLY BEING INSPECTED FOR. THIS IS THE FIRST OCCURRENCE OF ANY REPORTED FLICKERING WITH THE HANDLES SINCE THE IMPLEMENTATION OF A CONTACT PIN. CORRECTIVE ACTION WAS ALREADY IMPLEMENTED TO INTRODUCE A PIN WITHIN THE HANDLE DESIGN TO ASSIST IN CREATING A MORE STABLE CONTACT. AN EVEN MORE ROBUST CONTACT DESIGN WAS RECENTLY IMPLEMENTED TO ADDRESS THE ONGOING VARIOUS FACTORS THAT COULD LEAD TO AN UNSTABLE LIGHT. BOMIMED WILL CONTINUE TO COMPLETE STRINGENT HEIGHTENED TESTING AND WILL MONITOR THE INTERNAL AND EXTERNAL FEEDBACK

    Description of Event or Problem · 1

    LARYNGSCOPE WAS FLICKERING LOTS TO A POINT THAT WE HAD TO CHANGE IT WITH A NEW HANDLE AND BLADE TO DO THE INTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90716 BOMIMED LARYNGOSCOPE HANDLE CCW BOMIMED INC OL-334L6 2317

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention