Events

Alerte De Sécurité sur CATHETER SOUNDSTAR ECO and NAVIGATION SYSTEM EP - CARTO 3 System, Model - Catheters and Surgical Navigation System. Registration nº 80145901453. SERIAL NUMBER: NAVIGATION SYSTEM EP - CARTO 3 System: SNs: 50573; 51027; 51021; 50572; 11879; 51022; 50203; 51018; 51020; 50128; 11179; 50530; 50532; 5977

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; BIOSENSE WEBSTER INC.

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
  • ID de l'événement
    1725
  • Date
    2015-11-03
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    The company informs that there will be risk if the ultrasound image is being used to monitor the patient during the electrophysiology procedure. If there is a power outage during the ride, the ultrasound image will not reappear until the CARTO® 3 System is restored.
  • Cause
    The company holding the registry informs that the intracardiac ultrasound image will disappear if the power of the carto® 3 navigation system is interrupted and this may present a safety problem if the electrophysiologist is using ultrasound imaging to monitor the patient during the electrophysiology. the ultrasound image will not reappear until the carto® 3 system is restored.
  • Action
    • Read this Field Safety Notice carefully (Appendix). • Give this notice to the people at your facility who need to be informed about the problem, including relevant clinical professionals who are involved in the use of SOUNDSTAR® eco Catheters. • Keep a copy of this letter with the product. • Be aware of this Field Safety Notification

Device

CATHETER SOUNDSTAR ECO and NAVIGATION SYSTEM EP - CARTO 3 System, Model - Catheters and Surgical ...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; BIOSENSE WEBSTER INC