Events

Alerte De Sécurité sur Carto® 3 Systems

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
    2012-02-21
  • 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_20120221b.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
    Field safety notice: biosense webster carto® 3 systems the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning cartor 3 systems manufactured by biosense webster, inc. the manufacturer has recently become aware that some carto® 3 systems may be susceptible to ablation radio frequency interference through certain interconnected cable configurations. according to the manufacturer, the root cause has been determined to be a newly introduced patient interface unit (piu) backplane card. the new card is more sensitive to radio frequency interference, which will manifest as a jumping/ disappearing icon and/or error messages 105 and 319. biosense webster explained that while ablation at an unintended location could potentially happen as the result of undetected or ignored icon jumps, the likelihood of this happening is remote as the high detectability of icon jumps and the verification of catheter tip position with fluoro and/or ecg by operating physicians. as a result, the probability of a potential patient injury from icon jumps is unlikely and continued use of the carto® 3 systems remains safe and effective. biosense webster is going to replace the piu backplane card for the affected customers. meanwhile, customers are suggested to eliminate the radio frequency interference by utilizing the accessories provided with the customer notification. the notification also suggests ways to deal with the error messages. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Carto® 3 Systems
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Biosense Webster Carto® 3 Systems
  • Manufacturer
    Biosense Webster

Manufacturer

Biosense Webster