Events

Retiro De Equipo (Recall) de BIPAP AUTOSV WITH SMARTCARD INT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por VITALAIRE 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
    51661
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-07-06
  • 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
    Resmed has issued an urgent field safety notice that described a statistically significant 2.5 percent absolute increased annual risk of cardiovascular mortality for those randomized to a resmed adaptive servo ventilation (asv) therapy compared to the control group. in the patient population with reduced left ventricular ejection fraction (lvef = 45%) 10.0 percent of the asv group experienced a cardiovascular death each year compared to 7.5 percent of the control group representing a 33.5 percent relative increased risk of cardiovascular mortality (hr=1.335 95%ci=(1.070 1.666) p-value= 0.010).

Device

BIPAP AUTOSV WITH SMARTCARD INT
  • Modelo / Serial
    Model Catalog: 1044114 (Lot serial: ALL); Model Catalog: 1038916 (Lot serial: ALL); Model Catalog: 1044288 (Lot serial: ALL); Model Catalog: 1040718 (Lot serial: ALL); Model Catalog: 1044235 (Lot serial: ALL); Model Catalog: 1008628 (Lot serial: ALL); Model Catalog: CA1008628 (Lot serial: ALL); Model Catalog: 1044280 (Lot serial: ALL); Model Catalog: CA951S (Lot serial: ALL); Model Catalog: CA961S (Lot serial: ALL); Model Catalog: CA951HS (Lot serial: ALL); Model Catalog: CA961TS (Lot serial: ALL); Model Catalog: CA961NTS (Lot serial: ALL); Model Catalog: CA961HS (Lot serial: ALL); Model Catalog: 1044289 (Lot serial: ALL); Model Catalog: 1043343 (Lot serial: ALL); Model Catalog: 1111124 (Lot serial: ALL); Model Catalog: 1010771 (Lot serial: ALL); Model Catalog: 1044278 (Lot serial: ALL); Model Catalog: 1111122 (Lot serial: ALL)
  • Descripción del producto
    BIPAP AUTOSV WITH SMARTCARD INT
  • Manufacturer
    VITALAIRE CANADA INC.

Manufacturer

VITALAIRE CANADA INC.