Events

Retiro De Equipo (Recall) de QUBE COMPACT MONITOR

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
    142161
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-02-04
  • 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
    Spacelabs has received multiple reports of xprezzon and qube monitors failing to boot up or returning to factory default configuration settings following power on or reset. reported issues include: -a failure to boot following power on or reset resulting in a failure in monitor operation. -loss of network connectivity which may result in i) an inability to display alarms and data from the affected monitor on central stations and other bedside monitors or ii) a failure to transmit parameter and alarms from the affected monitor to system printers and spacelabs' intesys clinical suite retrospective database (including the clinical events interface remote notification feature). -display of english language when previously configured for another language (the alarm messages displayed in the parameter waveform zone are not affected as these are stored on a command module and not on the monitor). -touchscreen failure where touching the screen does not produce the expected response. the parameter alarms and information are still present and correct once the monitor has completely started up. no one has been injured as a result of these issues. spacelabs believes this issue is caused by inadequate electrical contact on one of its printed circuit board assemblies.

Device

QUBE COMPACT MONITOR
  • Modelo / Serial
    Model Catalog: 91390 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 91393 (Lot serial: > 10 lot numbers contact mfg)
  • Descripción del producto
    QUBE COMPACT MONITOR
  • Manufacturer
    SPACELABS HEALTHCARE (CANADA) INC.

Manufacturer

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