Events

Retiro De Equipo (Recall) de Device Recall McKesson Anesthesia Care System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por MCKESSON TECHNOLOGIES INC..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    66287
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1060-2014
  • Fecha de inicio del evento
    2013-03-15
  • Fecha de publicación del evento
    2014-03-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-05-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121944
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Gas-machine, anesthesia - Product Code BSZ
  • Causa
    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.
  • Acción
    McKesson sent a Clinical Alert dated March 15, 2013 to all affected customers. Additionally, phone calls were placed to each customer, followed up by an email to provide them written copies of the communication and Clinical Alert and obtaining acknowledgement that they have read and understand the issue and preventive actions to take. Customers with questions were instructed to contact McKesson Customer Support at 800-442-6767 (option 3). For questions regarding this recall call 404-338-3556.

Device

Device Recall McKesson Anesthesia Care System
  • Modelo / Serial
    MAC 14.3.1/MAC 14.3.1.1
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including CA, GA, IN, KY, MD, MI, OH, OK, and WA.
  • Descripción del producto
    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.
  • Manufacturer
    MCKESSON TECHNOLOGIES INC.

Manufacturer

MCKESSON TECHNOLOGIES INC.
  • Dirección del fabricante
    MCKESSON TECHNOLOGIES INC., 300 West Morgan St, STE 200, Durham NC 27701
  • Source
    USFDA