Events

Rappel de Device Recall McKesson Anesthesia Care System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par MCKESSON TECHNOLOGIES INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    66287
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1060-2014
  • Date de mise en oeuvre de l'événement
    2013-03-15
  • Date de publication de l'événement
    2014-03-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-05-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121944
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Gas-machine, anesthesia - Product Code BSZ
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    MAC 14.3.1/MAC 14.3.1.1
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including CA, GA, IN, KY, MD, MI, OH, OK, and WA.
  • Description du dispositif
    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.
  • Adresse du fabricant
    MCKESSON TECHNOLOGIES INC., 300 West Morgan St, STE 200, Durham NC 27701
  • Source
    USFDA