Events

Alerta De Seguridad para Adult / Pediatric Respirators Model 1000 Bear. Catalog number. 50-08550, 50-08555, 50-08560, 50-08570; Series No.s. from 11008756 to 11008959

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Bear Medical Systems Inc Sub Thermo Electron Corp.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    189
  • Fecha
    2000-10-27
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    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.
  • Acción
    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