Alerta De Seguridad para Giraffe Stand Alone Resuscitation Systems with Blender; Giraffe Warmer Integrated Resuscitation systems with Blender; Panda Warmer Integrated Resuscitation systems with Blender; Panda Freestanding Warmer Integrated Resuscitation Systems with Blender; and Resuscitation System field upgrade kits with Blender.

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
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • 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
    Medical device safety alert: ge healthcare resuscitation systems the australia therapeutic goods administration (tga) posted a medical device safety alert concerning the following products manufactured by ge healthcare: giraffe stand alone resuscitation systems with blender; giraffe warmer integrated resuscitation systems with blender; panda warmer integrated resuscitation systems with blender; panda freestanding warmer integrated resuscitation systems with blender; and resuscitation system field upgrade kits with blender. the manufacturer has recently become aware of a potential safety issue associated with the loosening of the blender knob shaft on all resuscitation units. a loose blender knob shaft may potentially affect the accuracy of the blended output of air/ oxygen gas mixture from the unit which could result in hypoxia or hyperoxia. the manufacturer advises users to perform a blender accuracy check as outlined in the service manual to verify the oxygen concentration set at 21% and 100% settings are within the recommended range. if the blender accuracy test results do not meet specification, users are advised to remove the system from patient use and contact the manufacturer. if the blender accuracy results pass, the system is suitable for continued use. however, the manufacturer recommends that a pulse oximeter should be used to monitor the patient when delivering oxygen. the manufacturer will correct all affected systems as a permanent fix. for details, please visit the following tga website:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01334-1 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 20 december 2013.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: GE Healthcare Resuscitation Systems
  • Manufacturer