BEUDAMED
    FDA Adverse Event Summary report: N

    BEAR 1000

    MDR report key: 64490 · Received January 23, 1997

    Report

    Report Number
    2022747-1997-00009
    Date Received
    January 23, 1997
    Date of Event
    December 20, 1996
    Report Date
    January 22, 1997
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    THE REPORT STATED THAT ANOTHER DEVICE FAILED WHILE IN USE ON 12/20/96 IN THE CARDIAC UNIT WITH AN E-39 ERROR CODE. THE SETTINGS WERE VT 700, RATE 12.40% OXYGEN, FLOW 50 L/M. NO PT INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEAR 1000 VOLUME VENTILATOR CBK ALLIED HEALTHCARE PRODUCTS, INC. 1000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention