Events

Rappel de CareSuite" Critical Care Manager, PACU Manager and Anesthesia Manager

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 Picis 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
    53897
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3277-2011
  • Date de mise en oeuvre de l'événement
    2009-08-12
  • Date de publication de l'événement
    2011-09-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-09-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86830
  • 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
    Software, transmission and storage, patient data - Product Code NSX
  • Cause
    Electronic health record software applications malfunctioned in a manner which failed to display the discontinued status for medication orders, as entered by the attending physician.
  • Action
    Picis Inc. sent a customer notification letter dated August 11, 2009 to all affected customers. The letter describes the product, problem, and action to be taken. Customers informed of the potential patient safety error were advised to make the appropriate configuration change, within current software versions 7.1.4 or later. Contact your local Picis support representative for questions regarding this notice.

Device

CareSuite" Critical Care Manager, PACU Manager and Anesthesia Manager
  • Modèle / numéro de série
    S/W version 7.1 release date - February 2004
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Brussels, Belgium, Denmark, Finland, France, Germany, Malaysia, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, and UK.
  • Description du dispositif
    CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager Software, transmission & storage, patient data. || This product is a non-alarming software patient information system that compiles an electronic medical record utilizing commonly available hardware. A patient record is populated with information from various sources, such as health care professionals, medical devices connected to the system, and data that arrives via hospital and laboratory information systems. The application stores this information in a database and displays it to healthcare providers in different formats for informational purposes. The product is intended for use by healthcare professionals.
  • Manufacturer
    Picis Inc.

Manufacturer

Picis Inc.
  • Adresse du fabricant
    Picis Inc., 100 Quannapowitt Parkway, Suite 405, Wakefield MA 01880
  • Société-mère du fabricant (2017)
    Constellation Software Inc
  • Source
    USFDA