Alerta De Seguridad para Warmair Model 134

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

¿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
    2011-10-06
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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
    Health canada type ii recall: warmair model 134 it has come to our attention that the health canada has issued a type ii recall on the cincinnati sub-zero products warmair model 134. the warmair 134 is used in conjunction with a single-patient use blanket to warm a patient's body temperature. one of the connectors attached to the warmair 134 device's printed circuit board can overheat. this may result in damage to the device's external case and/or melting of some of the internal components. for details, please refer to the following link: http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/ recall-retrait/_list/rec-ret_md-im_date_oct-dec_2011-eng.Php if you are in possession of the product, please contact your supplier or manufacturer for necessary actions or recommendations.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Warmair Model 134
  • Manufacturer

Manufacturer