Events

Alerta De Seguridad para Phototherapy units, visible light, for hyperbilirubinemia Children's heating systems with phototherapy option 8004/8010 Dr <umlaut> ager Babytherm Catalog codes: FR00098, FR00104, FR00105, FR00114, FR00120, 2M30404

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Draeger Medical Inc; Draeger Medizintechnik GmbH.

¿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
    319
  • Fecha
    2001-10-26
  • 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
    Systems for infant hyperthermia have plastic cable connectors that can become brittle and break during the time of use. pieces of these broken connectors may fall from the radiation heater above into the babytherm mattress.
  • Acción
    Please verify receipt of the letter and the response card dated March 9, 2001 from Draeguer Medical. Draeger Medical recommends that the Babytherm 8004/8010 mattress area be inspected immediately for pieces of plastic that may have fallen from the radiation heater located directly above the mattress. Draeger Medical claims that if the cable connectors become brittle and break, moving the unit can cause more breakage and falling of the pieces. All consumers must complete and return the reply card by mail at the address of the distributor above. DraegerService will contact you to arrange the replacement of plastic cable connectors with metal clips. The manufacturer initiated a correction by letter dated March 9, 2001. For more information, contact your local Draeger Medical representative

Device

Phototherapy units, visible light, for hyperbilirubinemia Children's heating systems with phototh...

Manufacturer

Draeger Medical Inc; Draeger Medizintechnik GmbH
  • Source
    ANVSANVISA