Events

Alerta De Seguridad para Packaging containing: 01 ESPRIT V1000 Respirator - Product Composition:. Car LX200, Support for F & P Humidifier; Optional Accessories Filters and Circuits: Inspiratory Bacteria Filter (Disposable) Inspiratory Bacteria Filter (Reusable) Exhaust Bacteria Filter (Reusable Omni) Disposable Exhaust Bacteria Filter (Package with 12) Adult Reusable Patient Circuit Kit a Reusable Bacteria Reagent Filter No. 1003847, Reusable Expiratory Bacteria Filter No. 1002970, Two Water Drains No. 1003648, Silicone Direct Coupling No. 500-1000-43) Disposable Patient Circuit Kit (The Kit includes: A Filter of Inspiratory Bacteria No. 1002504, A Disposable Exhalation Bacteria Filter No. 500-1000-09, Two Water Drugs No. 1002613, A Silicone Direct Coupling No. 500-1000-43) Flexible Brace, Flexible Brace Holder, Flexible Brace High Pressure Oxygen, Test Pulm, CA Electric Source Cable, Quick Reference Guide.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Respironics Califórnia, Inc..

¿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
    718
  • Fecha
    2003-07-02
  • 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
    The Technovigilance Unit will be accompanying the company's action in Brazil. Product Registered in Brazil for: HOMED EQUIPAMENTOS MEDICO HOSPITALAR LTDA - REGISTER NUMBER: 10320090011 - CNPJ 64.835.721 / 0001-02 - RUA: RUA UNAPITINGA, 32 - CITY: SAO PAULO - SP - PHONE: 011 - 530-3579 - FAX: 011 - 543-4366 - CEP: 04613070 - 07/31/2003: The company that owns the registration informs that it has not sold any equipment in Brazil. The company Homed, granted Dixtal Biomédica Industria e Comércio Ltda an import authorization and acquired from the manufacturer 9 equipment that is kept in its inventory, 1 of which is left on display for the knowledge of health professionals. The company points out that this exposure equipment had no contact with patients. The company also informs that the equipment was acquired after Recall made by the manufacturer.
  • Causa
    A material used to build three check valves on this fan predisposing it to premature failure, and its orientation on the fan could also have caused a problem. there were two patients injured, resulting in partial or complete failure to allow ventilation. there is a reasonable probability that the use of the product presents a high risk of serious adverse health consequences, including death.
  • Acción
    Recall Class I - A situation in which there is a reasonable likelihood that the use or exposure to a product will cause serious adverse health or death consequences.

Device

Packaging containing: 01 ESPRIT V1000 Respirator - Product Composition:. Car LX200, Support for F...

Manufacturer

Respironics Califórnia, Inc.
  • Source
    ANVSANVISA