BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAGER INC (CRITICAL CARE PRODUCTS ONLY)

    MDR report key: 593224 · Received April 15, 2005

    Report

    Report Number
    MW1035216
    Event Type
    Injury
    Date Received
    April 15, 2005
    Date of Event
    March 29, 2005
    Report Date
    April 6, 2005
    Manufacturer
    DRAGER INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE VENTILATOR FAILED TO DELIVER ADEQUATE AIR EXCHANGE. NO ALARM SOUNDED. OXYGEN WAS BEING DELIVERED AS EVIDENCED BY ADEQUATE OXYGEN SATURATION. CAPILLARY PH OF 6.6 SHOWED INADEQUATE REMOVAL OF CO2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAGER INC (CRITICAL CARE PRODUCTS ONLY) VENTILATOR, INFANT CBK DRAGER INC BABYLOG 8000 PLUS *

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Required Intervention