Events

Alerta De Seguridad para Commercial name: Intra-Operative Magnetic Resonance Imaging System Polestar N30 //// ANVISA record: 10339190462 /// Risk class: II. Affected model (s); PoleStar N-30 Systems and Batch (s) / Serial Number (s) Affected. One unit of system no. 3122 (distributed to São Paulo-SP).

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MEDTRONIC COMERCIAL LTDA; MEDTRONIC NAVIGATION ISRAEL, LTD..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1928
  • Fecha
    2016-06-28
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Recommendations to Users and Patients: Share this Urgent Security Notice with all those who work at your facility and use the PoleStar Surgical MRI System to have Medtronic perform an on-site inspection to verify and correct the ground connection on your PoleStar N -30. #### UPDATED ON 7/24/2017, Medtronic filed the field action completion report, verifying that the customer safety notice and equipment repair were submitted.
  • Causa
    Recently, in conducting internal tests, medtronic has identified a possible ground discontinuity in these subassemblies (warning light box and coolers), leading to a possible risk of electric shock to the user when in direct contact with these subsets. the risk assessment carried out concluded that the risk of electric shock to the user is low. in addition, the residual risk levels of the system have not changed and remain acceptable. in the medtronic risk assessment, there was no change in the risk to the patient since the assemblies were located outside the operating room. medtronic took immediate action to review and correct this problem. medtronic will perform an on-site inspection to verify and correct the ground connection on your polestar n-30 system.
  • Acción
    Correction in Parts and Parts Field /// Recommendations to users and patients. Action code FA725.

Device

Commercial name: Intra-Operative Magnetic Resonance Imaging System Polestar N30 //// ANVISA recor...

Manufacturer

MEDTRONIC COMERCIAL LTDA; MEDTRONIC NAVIGATION ISRAEL, LTD.
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA