Events

Safety Alert for Adult / Pediatric Respirators Model 1000 Bear. Catalog number. 50-08550, 50-08555, 50-08560, 50-08570; Series No.s. from 11008756 to 11008959

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Bear Medical Systems Inc Sub Thermo Electron Corp.

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
    189
  • Date
    2000-10-27
  • 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
    There is the possibility of corrosion of the mechanical relay that activates the alarm of energy fall in the respirators mentioned. the manufacturer initiated a correction by mail sent on june 2, 2000.
  • Action
    Make sure you have received the correspondence sent on June 2, 2000, by Bear Medical Systems. Identify any affected product in your inventory. For more information, contact your local representative or directly with Bear Medical Systems, Department of Technical Services at 1 (760) 778-7300 in the United States. ECRI recommends isolating any affected product and, where possible, using other replacement respirators - alternatives available - for patients requiring treatment

Device

Adult / Pediatric Respirators Model 1000 Bear. Catalog number. 50-08550, 50-08555, 50-08560, 50-0...

Manufacturer

Bear Medical Systems Inc Sub Thermo Electron Corp
  • Source
    ANVSANVISA