BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEAR

    MDR report key: 208850 · Received February 8, 1999

    Report

    Report Number
    2022747-1999-00009
    Event Type
    Injury
    Date Received
    February 8, 1999
    Date of Event
    December 16, 1998
    Report Date
    February 5, 1999
    Manufacturer
    BEAR MEDICAL SYSTEMS
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE ON PT, WITH 2 RN'S AND A RT AT BEDSIDE, THE VENTILATOR STOPPED WORKING AND STAFF NOTICED A "FIRE" SMELL FROM THE VENTILATOR. THE PT WAS IMMEDIATELY MANUALLY VENTILATED AND REMOVED FROM ROOM. PT REMAINED STABLE THROUGH OUT INCIDENT. NO PT COMPROMISE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEAR VOLUME VENTILATOR CBK BEAR MEDICAL SYSTEMS BEAR 3 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention