Events

Alerta De Seguridad para Resuscitation Systems with blender field upgrade installed in GE Giraffe and Panda Warmers

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

¿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
    2012-10-31
  • Fecha de publicación del evento
    2012-10-31
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121031a.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: ge resuscitation systems with blender field upgrade installed in ge giraffe and panda warmers the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning resuscitation systems with blender field upgrade installed in giraffe and panda warmers, manufactured by ge healthcare. according to the manufacturer, ge healthcare has recently become aware of a potential safety issue concerning the affected product where the oxygen and air wall inlet fittings and/or labels on the back panel, were reversed during assembly. as a result, this may potentially have reversed air/oxygen mixer concentrations; for example, a setting of 100% oxygen could have an output of 21% oxygen, and vice versa. the settings of the blender knob will no longer be accurate. the manufacturer recommended users to follow the instructions shown in the field safety notice to identify the affected resuscitation system. regarding affected unit in use with patient, the manufacturer advised users to disconnect the wall supply gas and switch to tank supply. once the patient no longer requires respiratory support, the patient should be transferred to another bed and the unit should be removed from service. the manufacturer will also arrange on-site repair for all affected devices. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con195935 if you are in possession of the product, please contact your supplier for necessary actions. posted on 31 october 2012.

Device

Resuscitation Systems with blender field upgrade installed in GE Giraffe and Panda Warmers
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: GE Resuscitation Systems with blender field upgrade installed in GE Giraffe and Panda Warmers
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare