BEUDAMED
    FDA Recall Terminated

    Servo Ventilator 300 (Model SV300) and Servo Ventilator 300 (Model SV300A). The SV300 is intended for general and critical ventilatory care for use on adults, pediatric, infant and neonatal patients. The unit is designed to be used at the bedside for intra-hospital transport.

    Recall: Z-1252-2009 · Initiated March 23, 2009

    Recall

    Recall Number
    Z-1252-2009
    Event Number
    51473
    Firm
    MAQUET Inc.
    FEI Number
    3008355164
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 23, 2009
    Posted
    May 12, 2009
    Terminated
    November 16, 2009
    Address
    1140 US Highway 22, Bridgewater, NJ, 08807-2958

    Description

    Servo Ventilator 300 (Model SV300) and Servo Ventilator 300 (Model SV300A). The SV300 is intended for general and critical ventilatory care for use on adults, pediatric, infant and neonatal patients. The unit is designed to be used at the bedside for intra-hospital transport.

    Reason

    The expiratory valve in the SV 300 ventilator may stay in the open position if the printed circuit board fails.

    Action

    An "Urgent: Device Correction" letter dated March 23, 2009 was sent by Federal Express to customers. The letter described the affected product, problem, indications, potential hazard and actions for users. Customers were instructed to complete the "Device Correction -- Customer Fax Response" form and return via fax (732-667-1903) to Maquet Inc. RA/QA. Direct questions to your local Maquet Inc. representative.

    Distribution

    Nationwide Distribution.

    Quantity

    7,847 units