Company:McKesson Technologies,.
Date of Enforcement Report:3/15/2014
Class I:
PRODUCT
McKesson Anesthesia Care
Use: The device is a computer-based system which collects, processes, and records data both through manual entry and from monitors which are attached to patients, such as in an 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.Z-1060-2014
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. Use of this affected product may cause serious adverse health consequences, including death.
RECALLING FIRM/MANUFACTURER
McKesson Technologies, Inc..,Durham, NC. on 3/15/20143.
VOLUME OF PRODUCT IN COMMERCE
10
DISTRIBUTION
Nationwide
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