Events

Safety Alert for 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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by VR MEDICAL LTDA; Carefusion Inc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2042
  • Date
    2016-12-23
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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
  • Reason
    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