Events

Safety Alert for Trade name: Pulmonary Fans. Technical Name: Fan Pressure and Volume. ANVISA registration number: 80659160003. Class of risk: III - High Risk. Affected Models: 1103050- FLEXIMAG - ADULT ELECTRONIC PEDIATRIC NEONATAL PULMONARY VENTILATOR 10.4POL (ANVISA Registry 80659160003, class III); 1103760- FLEXIMAG - NEONATAL PULMONARY PULMONARY FAN PEDIATRIC ADULT 15POL (ANVISA Registry 80659160003, class III); 1104970- FLEXIMAG PLUS - NEONATAL PULMONARY PULMONARY FAN PEDIATRIC ADULT 15 POL (ANVISA Registry 80659160003, class III)

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Magnamed Tecnologia Médica S/A.

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
    2057
  • Date
    2016-06-30
  • 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
    The manufacturer recommends that you do not use the PRVC mode without updating the software. 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
    In some cases of using the equipment in the prvc mode with the flow sensor having incorrect readings, the equipment may have a higher expired volume than the actual one and gradually reduce the pressure and tidal volume. the risk is considered moderate because the probability of occurrence is occasional and its severity is moderate, because the alarm of low tidal volume will sound. if there is no action on this alarm, it may cause harm to the patient.
  • Action
    Field Action Code 1 triggered under the responsibility of Magnamed Tecnologia Médica S / A. Field correction for software update.

Device

Trade name: Pulmonary Fans. Technical Name: Fan Pressure and Volume. ANVISA registration number: ...

Manufacturer

Magnamed Tecnologia Médica S/A