Events

Rappel de Picis 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
    60006
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0139-2012
  • Date de mise en oeuvre de l'événement
    2011-08-12
  • Date de publication de l'événement
    2011-10-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104224
  • 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
    Periop/critical care manager ehr software application displayed one patient's demographic and health information in place of another patient that was in current view.
  • Action
    Picis Inc. sent a "Safety Notification letter" dated August 12, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed until this service pack is applied, we recommend: * For patients who have been transferred from other facilities within the same VISN, you should discontinue the use of these Picis applications. Manually check the patient's name with that displayed in the Picis patient blue banner to ensure you catch all of these cases. * For all other patients, you may safely continue the use of these Picis applications. For further questions please call (781) 557-3000.

Device

Picis Anesthesia Manager
  • Modèle / numéro de série
    8.2 Service Pack 4 or higher.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution -- AZ, DE, FL, IL, NY, OH, PA, WI and WV.
  • Description du dispositif
    Picis Anesthesia Manager, PACU Manager,Critical Care Manager-8.2 Service Pack 4 or higher || (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