Events

Retiro De Equipo (Recall) de ULTRAVIEW SL COMMAND MODULE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SPACELABS HEALTHCARE (CANADA) 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
    18316
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-05-06
  • 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
    Potential hazard associated with the use of the spacelabs medical ultraview sl command module with the masimo spo2 pcba pn: 010-1636- 02.The reset sequence takes approximately 10 seconds and during this period monitoring of all parameters will be suspended. upon completion of the reset sequence all alarm limits will be reset to their site-defined default values. critical alarms for ventricular fibrillation and asystole are always enabled after the reset. if invasive pressure is being monitored labels will be reset to default values and the zero calibration will be lost. if non-invasive pressure is being monitored the automatic measurement mode will be disabled. a separate failure mode can also occur where the spo2 menu keys become unresponsive and prevent user changes to spo2 operation and alarm settings. in this state all alarm limits alarm functions and parameter monitoring continue unaffected and all alarm limits other than spo2 can still be adjusted.

Device

ULTRAVIEW SL COMMAND MODULE
  • Modelo / Serial
    Model Catalog: 91496 (Lot serial: > 10 lot numbers contact mfg)
  • Descripción del producto
    ULTRAVIEW SL COMMAND MODULE
  • Manufacturer
    SPACELABS HEALTHCARE (CANADA) INC.

Manufacturer

SPACELABS HEALTHCARE (CANADA) INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    OSI Systems Inc
  • Source
    HC