Events

Alerta De Seguridad para Oxylog Transport Ventilators

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Draeger 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
    2014-02-20
  • Fecha de publicación del evento
    2014-02-20
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140220b.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: draeger oxylog transport ventilators the australia therapeutic goods administration (tga) posted a medical device safety alert concerning oxylog transport ventilators manufactured by draeger medical. the affected model numbers are oxylog 3000plus and oxylog 2000plus, and the affected serial numbers are asej-0138 and asek-0011. the manufacturer has received reports of devices displaying the error message “poti unplugged”. the investigation has revealed that a limited batch of faulty control panel pcbs - onto which the potentiometer for setting the ventilation parameters is soldered. this can result in the contact to the respective potentiometer being interrupted. the device then discontinues ventilation, gives an audible alarm and displays the error message poti unplugged. the manufacturer advises users that if this error occurs they must immediately commence ventilation using an independent ventilator (manual ventilation bag) as specified in the instructions for use manual. furthermore, the manufacturer will be contacting all affected users to organise the correction of the affected devices. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to the following link:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00168-1 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 20 february 2014.

Device

Oxylog Transport Ventilators
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Draeger Oxylog Transport Ventilators
  • Manufacturer
    Draeger Medical GmbH

Manufacturer

Draeger Medical GmbH