Events

Alerta De Seguridad para maquet servo-i/s ventilator systems with software version 8.00.00

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

¿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
    2016-06-17
  • Fecha de publicación del evento
    2016-06-17
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160617.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: maquet servo-i/s ventilator systems with software version 8.00.00 the australia therapeutic goods administration (tga) has issued a medical device safety alert concerning servo-i/s ventilator systems with software version 8.00.00 [part numbers: 68 85 247, 68 85 259]. the manufacturer has become aware of improper behaviour introduced in servo-i and servo-s ventilator system sw version 8.00.00, which appears as follows:- if ventilation is started with infant factory default settings, the following settings will apply: pressure control mode; and 10 cmh2o pc above peep. the system will deliver a pressure of 20 cmh2o above peep as long as the factory default setting 10 cmh2o is used unchanged. according to the manufacturer, there is a risk of serious injury to an infant. however, the issue would be apparent in the pressure curve and peak pressure displayed on the screen. there are no reported injuries. users are advised to change the default settings of pressure above peep in the infant patient category. the ventilator will only deliver a pressure of 20 cmh2o above peep if the default start-up configuration of the pressure has not been changed. the manufacturer will be upgrading all affected units as a permanent correction. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 june 2016.

Device

maquet servo-i/s ventilator systems with software version 8.00.00
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Maquet SERVO-i/s ventilator systems with software version 8.00.00
  • Manufacturer
    MAQUET

Manufacturer

MAQUET