Events

Alerta De Seguridad para Product name: Patient Monitor Intellivue Technical Name: Vital Signs Monitor ANVISA Registration Number: 10216710215 Hazard Class: III Affected Model: MX400, MX400, MX500, MX500, MX700, MX800 Affected serial numbers: DE44307469, DE44307475, DE33105118, DE33105135, DE33105136, DE33105139, DE33105149, DE33105151, DE33105152, DE33105153, DE33105154.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Philips Medical Systems Ltda.; Philips Medizin Systeme Böblingen 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
    2301
  • Fecha
    2017-05-25
  • 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
    Immediately identify all affected cables, remove them from stock, and save them for exchange by a Philips Health Care Authorized Service Provider. Review this information with all members of your team who need to be aware of the content of this communication. It is important to understand the content of this communication.
  • Causa
    A small number of intellivue patient nmt cables may contain an insulation defect located in the throttle sensor housing shield. this manufacturing defect can cause localized heating due to unintentional current flow between the housing of the acceleration sensor attached to the thumb and the nmt stimulation electrode attachment attached to the hand pulse of the same hand.
  • Acción
    Field Action Code FCO86201777 triggered under the responsibility of the company Philips Medical Systems Ltda. Company will fix the equipment in stock.

Device

Product name: Patient Monitor Intellivue Technical Name: Vital Signs Monitor ANVISA Registration ...

Manufacturer

Philips Medical Systems Ltda.; Philips Medizin Systeme Böblingen GmbH.
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    ANVSANVISA