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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1060-2014

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.

Publicado el 12 de marzo de 2014 · Inicio del retiro: 15 de marzo de 2013

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Detalles del retiro

Fabricante
MCKESSON TECHNOLOGIES INC.
Distribuidor
Nationwide Distribution including CA, GA, IN, KY, MD, MI, OH, OK, and WA.
Lote
MAC 14.3.1/MAC 14.3.1.1
Clasificación de riesgo
Class I
Área (FDA)
device
País
United States

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