BEUDAMED
    FDA Enforcement Class I Terminated

    McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through manual entry and from monitors which themselves are attached to patients, such as in the operating room environment. The system provides clinical decision support by communicating potential Adverse Drug Event alerts proactively during the pre-anesthesia evaluation and at the point-of-care. The system is generally indicated in the anesthetizing environment when the anesthesia provider decides to perform a patient assessment, to generate a paper and/or electronic record of the administration of anesthesia to a patient, and to document care.

    Recall: Z-1060-2014 · Reported March 12, 2014

    Enforcement

    Recall Number
    Z-1060-2014
    Event ID
    66287
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    MCKESSON TECHNOLOGIES INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    March 12, 2014
    Initiation Date
    March 15, 2013
    Classification Date
    March 5, 2014
    Termination Date
    May 1, 2014
    Address
    300 West Morgan St, STE 200, Durham, NC, 27701, United States

    Description

    McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through manual entry and from monitors which themselves are attached to patients, such as in the operating room environment. The system provides clinical decision support by communicating potential Adverse Drug Event alerts proactively during the pre-anesthesia evaluation and at the point-of-care. The system is generally indicated in the anesthetizing environment when the anesthesia provider decides to perform a patient assessment, to generate a paper and/or electronic record of the administration of anesthesia to a patient, and to document care.

    Reason

    There was an occurrence where the patient case data did not match the patient data when the case was recalled in the Anesthesia Care Record (ACR) in that it included data from another case.

    Code Info

    MAC 14.3.1/MAC 14.3.1.1

    Distribution

    Nationwide Distribution including CA, GA, IN, KY, MD, MI, OH, OK, and WA.

    Quantity

    10