BEUDAMED
    FDA Recall Terminated

    Carina Home Ventilator. The device is used as a continuous respirator/ventilator for home use.

    Recall: Z-1263-2009 · Initiated January 21, 2009

    Recall

    Recall Number
    Z-1263-2009
    Event Number
    51447
    Firm
    Draeger Medical, Inc.
    FEI Number
    2517967
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 21, 2009
    Posted
    May 14, 2009
    Terminated
    January 5, 2010
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    Description

    Carina Home Ventilator. The device is used as a continuous respirator/ventilator for home use.

    Reason

    The device may not generate a pilot line disconnect alarm if the pilot line becomes disconnected, which may potentially result in a substantial reduction in tidal volume delivery.

    Action

    An "Urgent - Medical Device Recall" Letter dated January 2009 was issued to consignees via certified mail. The letter described the issue, specific conditions, background information, and precautions for customers. An additional letter dated January 22, 2009 was included with the "Urgent - Medical Device Recall" letter which instructed consignees to inform an enduser of the contents of the notification letter because some of the consignees are home care device/service providers. When the new hardware/software solution is available, affected devices will be updated free of charge. Direct questions about the notification letter to Drager Medical, Inc. by calling 1-800-543-5047 (press "1" at the prompt and then press "2349#"). Direct questions regarding updating your device when the new software is available, contact Drager Service Technical Support at 1-800-543-5047 (press "4" at the prompt).

    Distribution

    Nationwide Distribution -- states of CA, FL, GA, HI, IL, LA, MA, MN, OH, and TX.

    Quantity

    40 units