Events

Alerta De Seguridad para Trade name: Vital Signs Monitor DX2022 + ///. Technical Name: Vital Signs Monitor ///. ANVISA registration number: 10293490043 ///. Risk class: III - High Risk ///. Model affected: DX2022 + ///. Serial numbers affected: From 143300004 through 163302565

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Dixtal Biomédica Indústria e Comércio Ltda.

¿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
    2014
  • Fecha
    2016-10-14
  • 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 DX2022 + Vital Sign Monitor has the potential to present a problem in which the audio system may stop functioning causing the monitor to emit no sound. The problem can be corrected by restarting the equipment, but there is still the risk that the audio system will stop working again. For monitors with affected serial numbers, you should contact the company to schedule the fix. Contact: (92) 33062797 - reclamacao.philips.dixtal@philips.com
  • Causa
    During normal operation, the monitor may disable the audio system and no sound will be emitted by the equipment. when the monitor restarts, the system is re-established and the sounds are reissued, however, there is still a possibility that the audio system will stop working again. the visual alarm system will continue to operate normally. the frequency of this event is variable, and the problem may take days to occur. this problem may occur on all monitors with software versions sbmame08ar8 or lower. to date, there are no reports of adverse events related to this problem. /// caution: there is a risk of delayed patient treatment if there is an intercurrence or worsening of its state during the period that the monitor is disabled and the user does not perceive the visual signals on the screen or in the monitoring center .
  • Acción
    Field Action Nº DEDF1616 triggered under the responsibility of the company Dixtal Biomédica Indústria e Comércio Ltda. Company is doing update in the field for software update.

Device

Trade name: Vital Signs Monitor DX2022 + ///. Technical Name: Vital Signs Monitor ///. ANVISA reg...

Manufacturer

Dixtal Biomédica Indústria e Comércio Ltda
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    ANVSANVISA