BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH LITE DISP MILLER BLADE 0

    MDR report key: 3973409 · Received June 18, 2014

    Report

    Report Number
    1044475-2014-00167
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 23, 2014
    Manufacturer
    TELEFLEX
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, FUNCTIONAL AND DIMENSIONAL INVESTIGATION COULD NOT BE CONDUCTED SINCE THE COMPLAINT SAMPLE WAS NOT RETURNED FOR INVESTIGATION. A LOT NUMBER WAS NOT PROVIDED FOR A DHR (DEVICE HISTORY RECORD) REVIEW. THE COMPLAINT SAMPLE WAS NOT RETURNED FOR INVESTIGATION. THE COMPLAINT CANNOT BE CONFIRMED. NO CORRECTIVE/PREVENTATIVE ACTIONS ASSIGNED. ROOT CAUSE CANNOT BE ESTABLISHED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED, VIA MEDWATCH AS: THE CUSTOMER ALLEGES THAT DURING INTUBATION ATTEMPTS, THE CLINICIAN ENCOUNTERED BLADES THAT INITIALLY HAD WORKING LIGHTS. HOWEVER, WHILE THE BLADE WAS IN THE PT THROAT, THE BLADE LIGHT SUDDENLY WENT OUT AND THEN NO LONGER WORKED. INTERVENTION: THE USER FACILITY REPORTS THAT ADDITIONAL INTUBATION ATTEMPT WAS REQUIRED AND THE PT WAS SUCCESSFULLY INTUBATED. THERE WAS NO INJURY OR HARM TO THE PT. THE SURGERY (BEDSIDE SURGERY) WAS SUCCESSFUL AND THE PT WAS STABLE IN THE NICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357946 RUSCH LITE DISP MILLER BLADE 0 LARYNGSCOPE BLADE CCW TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Required Intervention