BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAGER

    MDR report key: 2964124 · Received February 12, 2013

    Report

    Report Number
    MW5028973
    Event Type
    Injury
    Date Received
    February 12, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 31, 2013
    Manufacturer
    DRAGER MEDICAL INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 A (B)(6) FEMALE ADMITTED WITH RECURRING UTI AND SEPSIS AND STAGHORN CALCULUS OF RIGHT KIDNEY. ON (B)(6) 2013 (1510) PATIENT INTUBATED AND PLACED ON MECHANICAL VENTILATION WITH THE EVITA 4. ON (B)(6) 2013 (1630) HEARD LOUD HIGH PITCHED ALARM COMING FROM ROOM, VENT SCREEN WENT BLANK AND MACHINE ALARMING AND EXTREMELY HOT. PATIENT WAS IMMEDIATELY REMOVED FROM VENT AND MANUAL BAGGING IMPLEMENTED. VENTILATOR WAS REPLACED AND PATIENT SUSTAINED NO CHANGE IN VITALS/ASSESSMENT DURING THE EVENT. ON (B)(6) 2013 PATIENT EXTUBATED AND PLACED ON 2L NASAL CANNULA. ON (B)(6) 2013 PATIENT STABLE AND DISCHARGED TO SKILLED FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60672 DRAGER EVITA 4 CBK DRAGER MEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention