BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRATION VENTILATOR SYSTEM

    MDR report key: 496507 · Received November 19, 2003

    Report

    Report Number
    3004023066-2003-00001
    Event Type
    Injury
    Date Received
    November 19, 2003
    Date of Event
    September 20, 2003
    Report Date
    October 20, 2003
    Manufacturer
    EVENT MEDICAL LTD
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS FOUND TO BE IN CARDIAC ARREST AND DISCONNECTED FROM THE VENTILATOR, THE VENTILATOR WAS ALARMING BOTH VISUALLY AND AUDIBLY. ADDITIONALLY A REVIEW OF THE ERROR LOG CONFIRMED THAT THE VENTILATOR ALARMED APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSPIRATION VENTILATOR SYSTEM VENTILATOR CBK EVENT MEDICAL LTD INSPIRATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| L| R