Events

Safety Alert for Non-invasive extra-thoracic ventilators Respironics, model NEV-100

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Respironics 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
    313
  • Date
    2001-10-12
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    All units manufactured between april 1992 and february 1999. a circuit failure may cause the above respirators to stop, shut down, and do not restart and / or exhibit smoke or smoke smell. the manufacturer initiated the correction by letter dated may 24, 1999.
  • Action
    Check receipt of the letter dated May 24, 1999 from Respironics. Discontinue use of the product as soon as possible. Your local Respironics representative should have contacted you to arrange the repair of the affected ventilators. If it has not already done so, call one of the numbers below and Respironics will help you have your ventilator (s) serviced at no charge. The manufacturer states that this correction must be completed by the end of 2001. For more information, contact your local representative or Respironics at 1 (412) 731-2100 (United States).

Device

Non-invasive extra-thoracic ventilators Respironics, model NEV-100

Manufacturer

Respironics Inc
  • Source
    ANVSANVISA