BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACHLIGHT WAND

    MDR report key: 112614 · Received August 13, 1997

    Report

    Report Number
    2425852-1997-00007
    Event Type
    Malfunction
    Date Received
    August 13, 1997
    Date of Event
    July 10, 1997
    Report Date
    July 14, 1997
    Manufacturer
    LAERDAL MEDICAL CORP.
    Product Code
    FCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MECHANICAL TESTING REPORTED BEING DONE IN THE INITIAL REPORT HAS BEEN CONCLUDED. BASED ON THE VISUAL INSPECTION, AND THE SIMULATED CYCLING, THE REPORTED TRACHLIGHT LIGHTWAND TIP FAILURE EXPERIENCED IN THE FIELD COULD NOT BE REPRODUCED IN LAB TESTING. THE FAILURE EXPERIENCED APPEARS TO BE AN ISOLATED INCIDENT THAT WAS EXACERBATED BY NOT USING LUBRICANT AS IS INDICATED BY THE DIRECTIONS FOR USE.

    Description of Event or Problem · 1

    DIFFICULT INTUBATION (GRADE IV LARYNGOSCOPY). DECISION FOR ALTERNATIVE MEANS FOR INTUBATION. TRACH LITE USED WITHOUT MAJOR DIFFICULTY. BREATH SOUNDS, CO2 CONFIRMED GOOD ETT PLACEMENT. PT COUGHED UP TIP OF TRACH LITE (PLASTIC TIP) ON FOLLOWING DAY. CXR NEGATIVE, BRONCH NEGATIVE FOR OTHER PARTICLES. TRACH LITE WAND WAS DISPOSED OF, AS IT IS SINGLE PT USE, BEFORE RECOGNIZED TIP WAS OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRACHLIGHT WAND LIGHTED STYLET FOR INTUB FCQ LAERDAL MEDICAL CORP. ADULT SINGL 10959

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR