Events

Alerte De Sécurité sur wato ex-55 and wato ex-65

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Shenzhen Mindray Bio-medical Electronics Co Ltd.

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
    2012-09-27
  • Date de publication de l'événement
    2012-09-27
  • 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_20120927.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: mindray wato ex-55 and wato ex-65 medical device manufacturer, shenzhen mindray bio-medical electronics co ltd, has issued a field safety notice concerning wato ex-55 and wato ex-65. in april 2012, mindray wato ex-55 and wato ex-65 anesthesia machines have been identified to have pneumatic circuit short connection issue and vaporizer manifold is slipped from pneumatic circuit. according to the manufacturer, the short connection may cause supply failure of the anesthesia agents which patient may become awake during operation. so far, only one clinical case had occurred in the mainland china involving wato ex-65 which the doctor applied proper methods to complete the operation. the root cause of the problem was identified to be due to one employee in the mainland china who did not follow the production process during the assembly. the manufacturer will recall and repair all the affected devices. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 27 september 2012.

Device

wato ex-55 and wato ex-65

Manufacturer

Shenzhen Mindray Bio-medical Electronics Co Ltd