Retiro De Equipo (Recall) de Picis Anesthesia Manager

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 Picis 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
    60006
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0139-2012
  • Fecha de inicio del evento
    2011-08-12
  • Fecha de publicación del evento
    2011-10-31
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2012-03-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Software, transmission and storage, patient data - Product Code NSX
  • Causa
    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.
  • Acción
    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

  • Modelo / Serial
    8.2 Service Pack 4 or higher.
  • Clasificación del producto
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- AZ, DE, FL, IL, NY, OH, PA, WI and WV.
  • Descripción del producto
    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

Manufacturer

  • Dirección del fabricante
    Picis Inc., 100 Quannapowitt Parkway, Suite 405, Wakefield MA 01880
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA