BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VEOLAR HAMILTON MEDICAL

    MDR report key: 261788 · Received February 8, 2000

    Report

    Report Number
    261788
    Event Type
    Injury
    Date Received
    February 8, 2000
    Date of Event
    January 31, 2000
    Report Date
    February 2, 2000
    Manufacturer
    HAMILTON MEDICAL INC
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS PLACED ON VENTILATOR. VENTILATOR WAS SET TO DELIVER 500CC FOR TIDAL VOLUME. ALARM SOUNDED. VENTILATOR WAS ACTUALLY DELIVERING 125CC. FLOW SENSOR WAS CHANGED, WORKED PROPERLY. MACHINE ALARMED 2ND TIME. ATTEMPTED TO CHANGE MODES, FAILED. VENTILATOR WAS CHANGED & TAKEN OUT OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VEOLAR HAMILTON MEDICAL VENTILATOR CBK HAMILTON MEDICAL INC 150107 *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention