Events

Alerte De Sécurité sur maquet servo-i/s ventilator systems with software version 8.00.00

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par MAQUET.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2016-06-17
  • Date de publication de l'événement
    2016-06-17
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160617.html
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Maquet SERVO-i/s ventilator systems with software version 8.00.00
  • Manufacturer
    MAQUET

Manufacturer

MAQUET