Events

Alerte De Sécurité sur Dornier Gemini lithotripter

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

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
    2018-02-22
  • Date de publication de l'événement
    2018-02-22
  • 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_20180223a.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: dornier medtech dornier gemini lithotripter medical device manufacturer, dornier medtech, has issued a medical device safety alert concerning its dornier gemini lithotripter [serial numbers: up to 152, as well as 158, 160 and 161]. through customer feedback, the manufacturer received information that the level of intensity of the shock wave application has increased unintendedly during treatment. the increase of intensity while applying shock waves is only possible in the model “kv change on the fly”. according to the manufacturer, its investigations traced back to an ergonomical issue of the touch panel, due to which the intensity can be increased by several light hits. it is possible to trigger the release unintendedly. the intensity is still limited to the maximal allowed intensity for treatment according to the operation manual, but unintended increase may also increase the occurrence rate of known side effects. the manufacturer decided to deactivate the failure triggering mode of “kv change on the fly” at the device to ensure patient safety. a service technician will conduct the necessary configurations during next service. after deactivation of the failure mode, adjustment of the intensity level during shock wave application is not allowed. the manufacturer is currently working on a solution to make the mode safely available again. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 february 2018.

Device

Dornier Gemini lithotripter
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Dornier MedTech Dornier Gemini lithotripter
  • Manufacturer
    Dornier MedTech

Manufacturer

Dornier MedTech