Events

Alerta De Seguridad para SONY LMD-1951MD Monitors used with SpyGlass

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Boston Scientific.

¿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
  • Fecha
    2015-03-12
  • Fecha de publicación del evento
    2015-03-12
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150312a.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: sony lmd-1951md monitors used with spyglass medical device manufacturer, boston scientific, on behalf of sony electronics inc., has issued a field safety notice concerning specific sony lmd-1951md monitors (material numbers: m00546120, m0054612s0, m0054612z0) used with spyglass. according to the manufacturer, the monitor may either not turn on, or may lose image during use in some situations. the issue is the result of a potential disconnection of the internal power supply caused by a failure of a power board integrated circuit. the failure mode does not occur when an ac adapter is used with the monitor. as a precautionary measure, the manufacturer asks all users to take the following actions. if users possess an ac adapter for each of the affected monitors, use only the ac adaptor when the monitors are in use. users who do not possess an ac adapter for each of the affected monitors should stop using the monitor and take the monitor out of service until the permanent corrective action described below is implemented. as a permanent corrective action, the manufacturer will replace the power board of all affected units with a redesigned power board that does not exhibit this failure mode. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 march 2015.

Device

SONY LMD-1951MD Monitors used with SpyGlass
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: SONY LMD-1951MD Monitors used with SpyGlass
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH