Events

Alerta De Seguridad para Draeger Infinity Acute Care System in Neonatal Mode

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
    2013-11-06
  • Fecha de publicación del evento
    2013-11-06
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131106.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 infinity acute care system in neonatal mode medical device manufacturer, draeger medical gmbh has issued a medical device safety alert concerning infinity acute care system (iacs) in neonatal mode using software versions vg2.0.3 and higher. it was found in a laboratory test that when a low spo2 (yellow) medium grade alarm was provoked and then paused by the user by using the alarm pause function, the device did not generate the spo2 (red) high grade life threatening spo2 low alarm on the cockpit or central station when the spo2 value was further decreased to reach the set alarm limit for the high grade life threatening spo2 alarm. the correct spo2 value was indicated on all devices and the manufacturer is not aware of any incidents during use on patient. draeger is developing a software upgrade to fix the defect. meanwhile, draeger advises the users not to pause the yellow spo2 low alarm without adequate patient monitoring. according to the local supplier, the affected products were distributed to hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 november 2013.

Device

Draeger Infinity Acute Care System in Neonatal Mode
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Draeger Infinity Acute Care System in Neonatal Mode
  • Manufacturer
    Draeger Medical GmbH

Manufacturer

Draeger Medical GmbH