Events

Alerte De Sécurité sur VENTilogic LS ventilators

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

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
    2014-01-14
  • Date de publication de l'événement
    2014-01-14
  • 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_20140114.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: weinmann medical technology ventilogic ls ventilators the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning ventilogic ls ventilators, manufactured by weinmann medical technology. details of the affected products are as follows: item numbers: 27130, 27700, 27710, 27750, 27940, 27950, 27951, 27960, 27970 powerboards: wm39890 index a and index b in extremely rare cases, a diode has failed due to an overload resulting from a voltage surge on the power board. this led to the ventilator failing, meaning that the patient's respiratory support was no longer guaranteed. the manufacturer has modified the layout and components of the affected power board to eliminate the possibility of future occurrence of this fault. devices which are currently in use for life-support ventilation among critical patients have priority and will be corrected by the manufacturer as quickly as possible. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con362312 if you are in possession of the product, please contact your supplier for necessary actions. posted on 14 january 2014.

Device

VENTilogic LS ventilators
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: WEINMANN Medical Technology VENTIlogic LS ventilators
  • Manufacturer
    WEINMANN Medical Technology

Manufacturer

WEINMANN Medical Technology