Events

Retiro De Equipo (Recall) de CARESUITE ANESTHESIA MANAGER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por PICIS CLINICAL SOLUTIONS 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
    134328
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-03-16
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    During picis post-market compliance activities it was identified that there were two customer reports of malfunction within critical care manager (electronic health record) application which can potentially impact the manual record keeping of clinical orders and since correct handling of medication or infusion orders documentation are potentially affected patient safety may be impacted.

Device

CARESUITE ANESTHESIA MANAGER
  • Modelo / Serial
    Model Catalog: MODEL/CATALOG #: 4220 (Lot serial: Not Applicable); Model Catalog: MODEL/CATALOG #: 4220 (Lot serial: S/W Version 5.1 or later); Model Catalog: MODEL/CATALOG #: 1110 (Lot serial: S/W Version 5.1 or later); Model Catalog: MODEL/CATALOG #: 1110 (Lot serial: Not Applicable); Model Catalog: MODEL/CATALOG #: 4245 (Lot serial: S/W Version 5.1 or later); Model Catalog: MODEL/CATALOG #: 4245 (Lot serial: Not Applicable)
  • Descripción del producto
    Caresuite Anesthesia Manager
  • Manufacturer
    PICIS CLINICAL SOLUTIONS INC.

Manufacturer

PICIS CLINICAL SOLUTIONS INC.