BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERVO-I

    MDR report key: 865176 · Received June 13, 2007

    Report

    Report Number
    8010042-2007-00080
    Event Type
    Death
    Date Received
    June 13, 2007
    Date of Event
    May 10, 2007
    Report Date
    May 10, 2007
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K063404
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET INC SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MFR PROVIDES PROD FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    RN AND RT REMOVED THE PT FROM THE VENTILATOR TO SUCTION AND PLACED THE VENTILATOR IN STAND-BY. FOLLOWING SUCTION, THE PT WAS RETURNED TO THE VENTILATOR. THE VENTILATOR WAS LEFT ON STAND-BY. AS THE CLINICIANS WERE LEAVING THE ROOM THE CARDIAC MONITOR ALARMED. CLINICIANS RETURNED TO BEDSIDE AND DISCOVERED THE VENTILATOR IN STAND-BY. THE VENTILATOR WAS THEN SWITCHED FROM STAND-BY TO VENTILATION. PT EXPIRED LATER IN THE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death