BEUDAMED
    FDA Recall Terminated

    Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Intended for use by medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients.

    Recall: Z-0485-2015 · Initiated October 29, 2014

    Recall

    Recall Number
    Z-0485-2015
    Event Number
    69728
    Firm
    Respironics California Inc
    FEI Number
    2518422
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 29, 2014
    Posted
    December 1, 2014
    Terminated
    June 7, 2016
    Address
    2271 Cosmos Ct, Carlsbad, CA, 92011-1517

    Description

    Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Intended for use by medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients.

    Reason

    If the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (PCBA) and short to ground. This may prevent the ventilator to switch to battery power if AC power is disrupted.

    Action

    Philips Healthcare sent an Urgent - Field Safety Notice to all affected consignees to inform them that Respironics is recalling the Esprit V1000 and Esprit/V200 Conversion ventilators because if the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (PCBA) and short to ground. This may prevent the ventilator to switch to battery power if AC power is disrupted. A high urgency audible alarm will sound alerting medical personnel of the loss of power. In the absence of AC power, failure of battery power will cause loss of ventilator support, which may result in hypercarbia or hypoxemia. The potential issue affects ventilators manufactured prior to 12/31/04 due to design of the fan/shroud assembly. Esprit V1000 and Esprit/V200 Conversion Ventilators manufactured after that affected date are not affected. Customers with concerns were instructed to contact a Philips Respironics representative at (800) 722-9377. For questions regarding this recall call 760-918-7300.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Ecuador, Egypt, Greece, Hong Kong, India, Italy, Korea, Lebanon, Malaysia, Mexico, Pakistan, Panama, Peru, Philippines, Saudi Arabia, Singapore, South Africa, Spain, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Vietnam, and Yemen.

    Quantity

    3,943 units total (3,071 units in US)