Events

Retiro De Equipo (Recall) de FLUID WARMING SYSTEM W/TWO PRESSURE INFUSERS/BUILT IN AIR DETECTOR CLAMP

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SMITHS MEDICAL CANADA LTD. (SIMS).

¿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
    91153
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-01-28
  • 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
    Smiths medical became aware of an issue with the printed circuit board assembly ("pcba") supplied for use in level 1 fast flow fluid warmers h1200-en-115v-us. the pcba supplier ducommun reported having supplied incorrect pcba components which could cause the fluid warmer to not function as intended. this issue may result in false over temperature alarms.

Device

FLUID WARMING SYSTEM W/TWO PRESSURE INFUSERS/BUILT IN AIR DETECTOR CLAMP
  • Modelo / Serial
    Model Catalog: H1200-EN-115V-US (Lot serial: S103B00239); Model Catalog: H1200-EN-115V-US (Lot serial: S103B00176); Model Catalog: H1200-EN-115V-US (Lot serial: S103B00140); Model Catalog: H1200-EN-115V-US (Lot serial: S103B00106); Model Catalog: H1200-EN-115V-US (Lot serial: S103B00093); Model Catalog: H1200-EN-115V-US (Lot serial: S103B00044); Model Catalog: H1200-EN-115V-US (Lot serial: S103B00280); Model Catalog: H1200-EN-115V-US (Lot serial: S103B00281); Model Catalog: H1200-EN-115V-US (Lot serial: S103B00116)
  • Descripción del producto
    LEVEL 1 FAST FLOW FLUID WARMERS
  • Manufacturer
    SMITHS MEDICAL CANADA LTD. (SIMS)

Manufacturer

SMITHS MEDICAL CANADA LTD. (SIMS)
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Smiths Group Plc
  • Source
    HC