Events

Alerte De Sécurité sur Commercial Name: Ventilator Pulmonary AVEA //. Technical Name: Pulmonary Ventilator //. ANVISA registration number: 80102510942 //. Risk class: III - High Risk //. Model: AVEASTD //. Serial numbers affected: Attached distribution map

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par VR MEDICAL LTDA; Carefusion Inc.

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
    2042
  • Date
    2016-12-23
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    See the Letter to customers issued by the manufacturer. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Cause
    Potential risk associated with the avea ventilator ventilator caused by a malfunction of a pressure transducer. the pressure transducer malfunction is detected, the ventilator triggers an alarm and, as designed, the ventilation ceases and opens the safety valve to the atmosphere, allowing the spontaneous breathing of the patients able to do so.
  • Action
    Field Action Code AC 1/15 triggered under the responsibility of the company VR MEDICAL LTDA. Company is doing correction in the field.

Device

Commercial Name: Ventilator Pulmonary AVEA //. Technical Name: Pulmonary Ventilator //. ANVISA re...

Manufacturer

VR MEDICAL LTDA; Carefusion Inc
  • Source
    ANVSANVISA