BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WELCH-ALLYN, INC.

    MDR report key: 367768 · Received December 13, 2001

    Report

    Report Number
    367768
    Event Type
    Injury
    Date Received
    December 13, 2001
    Date of Event
    August 27, 2001
    Report Date
    October 18, 2001
    Manufacturer
    *
    Product Code
    EQN
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LARYNGOSCOPE, BLADE FAILED DURING AN INTUBATION ATTEMPT. THE BLADE BECAME PARTIALLY SEPARATED AND UNUSABLE. BLEEDING WAS OBSERVED AND THE PATIENT REQURIED A SURGICAL AIRWAY. UPON INSPECTION, THE BLADE FAILED AT THE SOLDERING JOIN BETWEEN ITS CONNECTION TO THE LARYNGOSCOPE HANDLE AND THE BLADE ITSELF. HOSPITAL PERSONNEL WERE UNABLE TO REUSUALLY DETERMINE WHAT PRECIPITATED THE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56507 WELCH-ALLYN, INC. LARYNGOSCOPE BLADE EQN * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening| R