Events

Rappel de BIPAP AUTOSV WITH SMARTCARD INT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par VITALAIRE CANADA INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    51661
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-07-06
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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)
  • Description du dispositif
    BIPAP AUTOSV WITH SMARTCARD INT
  • Manufacturer
    VITALAIRE CANADA INC.

Manufacturer

VITALAIRE CANADA INC.