Events

Alerta De Seguridad para MEDUMAT Transport Ventilator

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Weinmann Emergency Medical Technology GmbH & Co. KG.

¿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
    2013-10-22
  • Fecha de publicación del evento
    2013-10-22
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131022a.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: weinmann medumat transport ventilator the medicines and healthcare regulatory agency (mhra), united kingdom has posted a field safety notice concerning medumat transport ventilator (with and without co2 measurement) manufactured by weinmann emergency medical technology gmbh & co. kg. all the serial numbers are affected. according to the manufacturer, in some cases medumat transport ventilators have failed as a result of a device-internal fault. there is the potential risk of this fault recurring sporadically in future too. furthermore, according to the manufacturer, in the interaction of the internal structural components and sensors for internal device monitoring, device internal occurrences of this kind may coincide unfavourably, resulting in an undefined operating state and the device displaying a "device malfunction" for safety reasons. the manufacturer has developed new device software version 2.35. moreover, affected users are advised to take the following necessary actions: all medumat transport devices must be verifiably updated with the new xc firmware version 2.35 and embedded pc version 2.35. affected users can continue to use their medumat transport devices until the update has been installed. users are reminded to observe the recommendations and the addition to the instructions for use as mentioned in this field safety notice. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con323827 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 october 2013.

Device

MEDUMAT Transport Ventilator

Manufacturer

Weinmann Emergency Medical Technology GmbH & Co. KG