Events

Retiro De Equipo (Recall) de Single Use Breathing Circuit with Flow Sensor for OSIRIS3 Emergency Ventilator

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por Air Liquide Medical Systems SA.

¿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
  • Fecha
    2011-02-22
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/circuit-respiratoire-usage-unique-avec-capteur-de-debit-pour-ventilateur-d-urgence-osiris3-air-liquide-medical-systems-s-a--rappel-de-lot
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Notas adicionales en la data
  • Acción
    Air Liquide Medical Systems SA has withdrawn batches 101151977 and 110152448 from the reference KG020000 of the medical device called: Single-use breathing circuit with flow sensor for emergency ventilator OSIRIS3, manufactured by Flexicare (UK). Indeed, the two lots concerned were equipped with the wrong reference flow sensor. The flow measurement performed is reduced. This induces errors on the measurement of the expired volume of the order of 20% (lower volume). . Air Liquide Medical Systems SA has directly notified the recipients of the incriminated lots by means of the message attached (22/02/2011) (35 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities will be informed of this measure by the manufacturer.

Device

Single Use Breathing Circuit with Flow Sensor for OSIRIS3 Emergency Ventilator

Manufacturer

Air Liquide Medical Systems SA