Events

Retiro De Equipo (Recall) de AQUAVENT LIMB FOR OXYGEN THERAPY ADULT HEATED

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

¿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
    144629
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-09-28
  • 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
    Armstrong medical ltd is investigating the heater wire retainer (located in the heated limbs of adult corrugated heated ventilator and cpap breathing circuits as a means to locate the heater wire in a fixed position). the retainer is white or off-white in color and made from polymeric (plastics) material. if breakage of this component were to occur there could be a possible inhalation risk to the patient.

Device

AQUAVENT LIMB FOR OXYGEN THERAPY ADULT HEATED
  • Modelo / Serial
    Model Catalog: AMCP1409/004 (Lot serial: 080310 TO 310812); Model Catalog: AMCPSI01052 (Lot serial: 080310 TO 310812); Model Catalog: AMCPUK01103 (Lot serial: 080310 TO 310812); Model Catalog: AMVC1792/130 (Lot serial: 080310 TO 310812); Model Catalog: AMVC1774/101 (Lot serial: 080310 TO 310812); Model Catalog: AMVC1774/102 (Lot serial: 080310 TO 310812); Model Catalog: AMVC1774/105 (Lot serial: 080310 TO 310812); Model Catalog: AMVC1774/106 (Lot serial: 080310 TO 310812); Model Catalog: AMVC1775/101 (Lot serial: 080310 TO 310812); Model Catalog: AMVC1775/102 (Lot serial: 080310 TO 310812); Model Catalog: AMVC1775/106 (Lot serial: 080310 TO 310812); Model Catalog: AMVC1775/108 (Lot serial: 080310 TO 310812); Model Catalog: AMCPUK01109 (Lot serial: 080310 TO 310812); Model Catalog: AMCP1409/003 (Lot serial: 080310 TO 310812)
  • Descripción del producto
    AQUABENT LIMB FOR OXYGEN THERAPY ADULT HEATED
  • Manufacturer
    CARESTREAM MEDICAL LTD

Manufacturer

CARESTREAM MEDICAL LTD