BEUDAMED
    FDA Recall Terminated

    The Ultraview SL 91517 Capnography module is a mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient's ventilatory, circulatory, and metabolic status. Mainstream monitoring uses a self-calibrating CO2 sensor to ensure continuous monitoring without interruption of connection. Reusable, lightweight (<14 grams), or single-use airway adapters are available for both adult and neonatal (low dead space) patients. Respiration can be monitored via an airway adapter and endotracheal or tracheostomy tubes using the mainstream function of the module. The intended use statement that apply to the 91517 are continuous monitoring of carbon dioxide and oxygen. The Model 95000-A Bedside/Transport Monitor is used at the patient's bedside to actively acquire, analyze, monitor and display a variety of clinical parameters (in clinically relevant formats) for adults, pediatric or neonatal patients. The Model 95000-A Bedside/Transport Monitor is designed for use by a healthcare professional in a hospital, healthcare facility (i.e., clinic), or intra-hospital transport. This product is not designed for home use or for use in transport vehicles.

    Recall: Z-2573-2011 · Initiated May 12, 2011

    Recall

    Recall Number
    Z-2573-2011
    Event Number
    58811
    Firm
    Spacelabs Healthcare, Llc
    FEI Number
    3010157426
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 12, 2011
    Posted
    June 20, 2011
    Terminated
    December 2, 2011
    Address
    5150 220th Ave Se, Issaquah, WA, 98029-6834

    Description

    The Ultraview SL 91517 Capnography module is a mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient's ventilatory, circulatory, and metabolic status. Mainstream monitoring uses a self-calibrating CO2 sensor to ensure continuous monitoring without interruption of connection. Reusable, lightweight (<14 grams), or single-use airway adapters are available for both adult and neonatal (low dead space) patients. Respiration can be monitored via an airway adapter and endotracheal or tracheostomy tubes using the mainstream function of the module. The intended use statement that apply to the 91517 are continuous monitoring of carbon dioxide and oxygen. The Model 95000-A Bedside/Transport Monitor is used at the patient's bedside to actively acquire, analyze, monitor and display a variety of clinical parameters (in clinically relevant formats) for adults, pediatric or neonatal patients. The Model 95000-A Bedside/Transport Monitor is designed for use by a healthcare professional in a hospital, healthcare facility (i.e., clinic), or intra-hospital transport. This product is not designed for home use or for use in transport vehicles.

    Reason

    Capnography Module, Model 91517, resets 20 seconds after power failure, instead of after three minutes as specified. This reset clears the RAM and the module returns to default settings.

    Action

    Spacelabs Medical sent a "URGENT-MEDICAL DEVICE CORRECTION" letter dated May 12, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken. Customers were recommended to set all their Capnography Module Configuration Manager alarm settings to "ON". The letter also recommended that customers brief their staff about the possibility of losing changes to the default settings and to restore them after a power interruption. A field service engineer will be contacting customers to set up a date and time when affected modules can be upgraded at no cost to the customer. For questions about this corrective action program, call Spacelabs Medical at 1-800-522-7025, Select 2 for Technical Support. For outside the US, customers can call 1-425-657-7200, x5089.

    Distribution

    Worldwide Distribution--USA (nationwide) and countries of ALGERIA, ARGENTINA, AUSTRALIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA,COLOMBIA, CYPRUS, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, ISRAEL, ITALY, JORDAN, KUWAIT, LEBANON, MALAYSIA, MEXICO, MOROCCO, NEPAL, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PALESTINE, PANAMA, PERU, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, REPUBLIC OF CHINA, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, and VIET NAM.

    Quantity

    5883 units