Events

Alerte De Sécurité sur CARTOSOUND Module of the CARTO 3 EP Navigation System

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

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
    2015-10-02
  • Date de publication de l'événement
    2015-10-02
  • 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_20151002b.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: biosense webster cartosound module of the carto 3 ep navigation system medical device manufacturer, biosense webster, has issued a medical device safety alert concerning its cartosound module of the carto 3 ep navigation system, [catalogue number: c3sound] when used with the soundstar eco 8f and eco 10f diagnostic ultrasound catheter, [catalogue number: 10439236, 10439072, 10439011 & 10438577]. the manufacturer has received one complaint of image disappearance from the cardiac ultrasound system when the carto 3 ep navigation system needed restarting. this occurred while the patient was experiencing pericardial effusion. based on medical evaluation of the health risk profile, the manufacturer believes that the likelihood of harm to the patient is generally low if the ultrasound imaging is not available. however, if the intra-cardiac ultrasound is used to actively monitor an ongoing effusion, the lack of imaging may present a safety issue due to the delay in procuring the resources/equipment to use another imaging modality. the manufacturer will be updating the product labeling to include and further reinforce the above-mentioned precautionary safety information. according to the local supplier, the affected product [cartosound module for the cartro 3 ep navigation system] is distributed to hospitals in hong kong for demonstration purposes. however, soundstar eco 8f and eco 10f catheter are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 october 2015.

Device

CARTOSOUND Module of the CARTO 3 EP Navigation System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Biosense Webster CARTOSOUND Module of the CARTO 3 EP Navigation System
  • Manufacturer
    Biosense Webster

Manufacturer

Biosense Webster