Events

Alerta De Seguridad para Babytherm Infant Warmers

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

¿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
    2014-09-02
  • Fecha de publicación del evento
    2014-09-02
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140902a.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: dräger babytherm infant warmers medicines and healthcare products regulatory agency (mhra), united kingdom, has issued a medical device safety alert concerning babytherm infant warmers [model no.: 8000wb, 8004 and 8010], manufactured by dräger medical gmbh. the manufacturer became aware of a case in which a side panel on a babytherm 8010 did not fully slide to the bottom in the corner guides and was not completely locked. the side panel did not open during this incident and no patient was affected. when reviewing the locking mechanism in a number of hospitals, it was possible to fully close the side panels by pushing down on them slightly. however, it cannot be guaranteed that the panel will lock in to position under its own weight. affected users should contact the manufacturer, if they have found that the locking mechanism is not functioning. the manufacturer is advising affected users to pay attention to the information provided in the instructions for use (ifu): “check that the side panels lock securely into position and that they remain securely locked” for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con448384 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 sep 2014.

Device

Babytherm Infant Warmers
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Dräger Babytherm Infant Warmers
  • Manufacturer
    Dräger Medical GmbH

Manufacturer

Dräger Medical GmbH