BEUDAMED
    FDA Recall Terminated

    Esprit Ventilator, Model Number V1000, Power Supply PN 1015852 and Power Supply Field Replacement Unit (FRU) PN, Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics 1018246

    Recall: Z-0047-2007 · Initiated August 8, 2006

    Recall

    Recall Number
    Z-0047-2007
    Event Number
    36161
    Firm
    Respironics California Inc
    FEI Number
    2518422
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 8, 2006
    Posted
    October 19, 2006
    Terminated
    January 8, 2010
    Address
    2271 Cosmos Ct, Carlsbad, CA, 92009-1517

    Description

    Esprit Ventilator, Model Number V1000, Power Supply PN 1015852 and Power Supply Field Replacement Unit (FRU) PN, Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics 1018246

    Reason

    This action is being initiated due to power supply snubber board failures on certain Esprit Ventilators in countries that utilize operating voltages of 200-240 Volts AC and will involve the replacement of the Esprit Ventilator power supply snubber board. Returned power supplies have shown evidence of overheating and in some cases in which a fan also failed, have shown signs of fire damage.

    Action

    The field action will be conducted through consignees (distributors) in the affected countries. The distributors were notified of the field action by Federal Express au on August 8th, 2006. The distributors have been informed that Respironics will provide replacement circuit boards at no cost and will be instructed to upgrade the ventilator power supplies in their region. Instructions have been provided to the distributors and users on how to evaluate the ventilator to be able to continue to use it pending the completion of the upgrades. The distributors will document the replacement of the affected component by signing and dating the activity on the Ventilator Field Action Log (reference sample on Appendix IV). The serial number of the power supply destroyed will also be recorded on the log.

    Distribution

    Worldwide, including Algeria, Argentina, Australia, Bangladesh, Brazil, Cambodia, Chile, Egypt, France, Hong Kong, India, Italy, Jordan, Lebanon, Malaysia, Pakistan, Peru, Philippines, Russia, S Africa, S Korea, Spain, Thailand, Turkey, United Kingdon, & Vietnam

    Quantity

    950