Events

Retiro De Equipo (Recall) de VPAP ADAPT SV

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
    101419
  • Clase de Riesgo del Evento
    I
  • 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
    A serious safety concern has been identified during the preliminary primary data analysis from the serve-hf clinical trial. this trial investigated the effect of adaptive servo- ventilation (asv) therapy on the hospitalization and mortality rate of patients with symptomatic chronic heart failure (nyha 2-4) with reduced left ventricular ejection fraction (lvef = 45%) and moderate to severe predominant central sleep apnea (ahi ? 15/h cahi/ahi ? 50% and cai ? 10/h).

Device

VPAP ADAPT SV
  • Modelo / Serial
    Model Catalog: 26013 (Lot serial: ); Model Catalog: 26008 (Lot serial: ); Model Catalog: 36007 (Lot serial: ); Model Catalog: 36007A (Lot serial: ); Model Catalog: 36057 (Lot serial: ); Model Catalog: 36047 (Lot serial: ); Model Catalog: 36037 (Lot serial: ); Model Catalog: 25107 (Lot serial: ); Model Catalog: 25102 (Lot serial: ); Model Catalog: 37216 (Lot serial: ); Model Catalog: 26002 (Lot serial: ); Model Catalog: 37215 (Lot serial: ); Model Catalog: 36017 (Lot serial: ); Model Catalog: 36027 (Lot serial: ); Model Catalog: 36000 (Lot serial: ); Model Catalog: 36050 (Lot serial: ); Model Catalog: 36010 (Lot serial: ); Model Catalog: 36048 (Lot serial: ); Model Catalog: 25005 (Lot serial: ); Model Catalog: 36058 (Lot serial: )
  • Descripción del producto
    VPAP ADAPT SV
  • Manufacturer
    VITALAIRE CANADA INC.

Manufacturer

VITALAIRE CANADA INC.