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Recall Observatory FDA recall evidence

Device product

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.

Z-1060-2014

March 15, 2013

Class I

Product summary

Firm
MCKESSON TECHNOLOGIES INC.
Event
Event 66287
Status
Terminated
Classification
Class I
Quantity
10
Official record key
device-enforcement:Z-1060-2014

Official wording

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 information: MAC 14.3.1/MAC 14.3.1.1

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.