Events

Alerte De Sécurité sur Humidifier

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Fisher & Paykel Healthcare Limited.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    I1506-239
  • Numéro de l'événement
    2014DM-0011418
  • Date
    2015-06-05
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=178
  • Notes / Alertes
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer states that the referenced devices may not be able to deliver air or oxygen flows to the patient when the power line is interrupted, leading to possible adverse events on the patients.

Device

Humidifier
  • Modèle / numéro de série
    AIRVO 2 and myAIRVO 2, References PT101xx and PT100xx, serial 120521yyyyyyy until 160605yyyyyyy.
  • Description du dispositif
    The MY AIRVO 2 is intended for the treatment of patients who breathe spontaneously and who would benefit from the administration of high-flow heated and humidified respiratory gases. Patients who have undergone surgery to receive a bypass in the upper respiratory tract would also fit within this group. The flow can be between 2 - 60 l / min according to the patient's interface. The MY AIRVO 2 should be used in patients at home or in long-term care centers. The AIR 2 is intended for the treatment of patients who breathe spontaneously and who would benefit from the administration of heated and humidified high-flow respiratory gases. Patients who have undergone surgery to receive a bypass in the upper respiratory tract would also fit within this group. The flow can be between 2 - 60 l / min according to the patient's interface. The AIRVO 2 should be used in hospitalized patients or in long-term care centers.
  • Manufacturer
    Fisher & Paykel Healthcare Limited

Manufacturer

Fisher & Paykel Healthcare Limited