BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8.5MM HI LO

    MDR report key: 191977 · Received October 13, 1998

    Report

    Report Number
    9681384-1998-00071
    Event Type
    Injury
    Date Received
    October 13, 1998
    Date of Event
    September 11, 1998
    Report Date
    October 12, 1998
    Manufacturer
    MMJ SA DE CV
    Product Code
    BTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    FACILITY REPORTED "FIRE AT ETT CUFF FOR 5-6 SECONDS AFTER NOTING FLAME FROM PATIENTS NECK." IN A SUBSEQUENT WITH BIO-MEDICAL ENGINEER, HE STATED THAT THERE WAS NO PROBLEM WITH THE PRODUCT, THE CUFF WAS IGNITED BY THE ELECTROCAUTERY DEVICE. MALLINCKRODT'S INSTRUCTIONS FOR USE CLEARLY CONTRAINDICATES THE USE OF AN ELECTROSURGICAL ACTIVE ELECTRODE IN THE IMMEDIATE AREA OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8.5MM HI LO ENDOTRACHEAL TUBE BTR MMJ SA DE CV NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention