BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACH LIGHT WAND

    MDR report key: 112611 · Received August 13, 1997

    Report

    Report Number
    112611
    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
    User Facility report
    Reporter Location
    MS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    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 IS SINGLE PT USE BEFORE RECOGNIZED TIP WAS OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRACH LIGHT WAND INTUBATION DEVICE FCQ LAERDAL MEDICAL CORP. * 10959

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other WAND HAD BEEN DISPOSED OF EARLIER PRIOR TO| TIP RETAINED BY RUSH FOUNDATION HOSPITAL.| DISCOVERY AS FOR SINGLE PT USE.