Events

Alerta De Seguridad para LCD MONITOR SONY, Model LMD-1951 MD Registration 80102510940, Serial numbers: 3000038 to 3004884, 3100035 to 3100058 and 3100065 to 3100145

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA; Sony Corporation.

¿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
    1551
  • Fecha
    2015-03-11
  • 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 company clarifies that the use of the affected equipment may cause the procedure to be suspended due to the shutdown defect mode of the monitor, requiring an alternative technique during the procedure if the monitor turns off and does not allow viewing.
  • Causa
    Vr medical informs that, through a statement issued by sony brazil, it was informed of the need to replace the power plate of the anvisa 80102510940 lcd monitors. this need arises from the fact that the monitors do not turn on or lose the image during the clinical use. according to manufacturer's investigation the problem is due to a disconnection of the internal power supply caused by failure in the integrated circuit of the power board. it was reported that up to now in brazil there have been no reports of adverse events associated with this mode of defect.
  • Acción
    The company directs users who own affected equipment to follow the guidelines outlined in the SONY Communiqué: 1) If you have an AC adapter (AC-110MD) for each of your affected monitors, only use the AC adapter when the monitors are in use; 2) If you do NOT have an AC adapter (AC-110MD) for each of the affected monitors, stop using the operation monitor until the permanent corrective measure is deployed. For more information, access the appendix Customer Information - Sony LCD Monitor

Device

LCD MONITOR SONY, Model LMD-1951 MD Registration 80102510940, Serial numbers: 3000038 to 3004884,...

Manufacturer

VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA; Sony Corporation
  • Source
    ANVSANVISA