Events

Alerta De Seguridad para maquet heart-lung machine hl 30

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

¿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
    2013-02-08
  • Fecha de publicación del evento
    2013-02-08
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130208.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: maquet heart-lung machine hl 30 medical device manufacturer, maquet cardiopulmonary ag issued a medical device safety alert concerning heart-lung machine hl 30. the manufacturer has identified two potential issues with the hl30 devices which will be addressed in a software upgrade: first, in rare instances, as a result of an accidental impact or 'bump' to the pump head cover, the unit may stop. this stoppage is intended to occur by design, whenever the pump head cover is opened during operation. however, if the impact is rapid, the unit may stop without an informational message explaining the reason behind. second, there is a software anomaly in the cardioplegia module whereby, in a limited number of cases, the unit slave pump did not engage after cardioplegia pause. no patient injury has been reported in either issue. the local supplier confirmed that the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 8 february 2013.

Device

maquet heart-lung machine hl 30
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: MAQUET Heart-lung Machine HL 30
  • Manufacturer
    MAQUET Cardiopulmonary AG

Manufacturer

MAQUET Cardiopulmonary AG