BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAR 1000

    MDR report key: 87916 · Received May 1, 1997

    Report

    Report Number
    2022747-1997-00050
    Event Type
    Malfunction
    Date Received
    May 1, 1997
    Date of Event
    March 23, 1997
    Report Date
    April 30, 1997
    Manufacturer
    21ST CENTURY SCIENTIFIC, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE OXYGEN MONITOR DISPLAYED A DECREASED FI02, THE VENTILATOR'S FRONT PANEL WENT BLANK, NO POWER, AND NO ALARM. AFTER 30 SECONDS, THE UNIT CAME BACK WITH AN E38 ERROR CODE, AND IN DIFFERENT SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEAR 1000 VOLUME VENTILATOR CBK 21ST CENTURY SCIENTIFIC, INC. 1000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention