Notificaciones De Seguridad De Campo acerca de Capnostream

Según ALIMS (Agencija za lekove i medicinska sredstva), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Serbia que fue producido por Covidien Respiratory and Monitoring Solutions.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2016-05-17
  • Fecha de publicación del evento
    2016-05-25
  • País del evento
  • Fuente del evento
    ALIMSA
  • URL de la fuente del evento
  • Notas / Alertas
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 recall data from the U.S. and Serbia.
  • Notas adicionales en la data
  • Causa
    Medtronic has received seven reports of thermal damage for a total of 9871 battery packs, delivered with the specified pulse oximeter. one of these seven reports involved a fire, which led to smoke inhalation and minor burns. after determining that the cause of this adverse event was a supplier error in battery production that could increase the risk of thermal damage to the battery pack, medtronic decided to take the field safety corrective action in the form of removing the disputed battery pack and issuing specific instructions that concerning the safe use of the medical device 'capnostream, model: 20; 20p ”, without a battery pack, and until the company produces new battery packs and replaces them with customers.

Device

Manufacturer

  • Empresa matriz del fabricante (2017)
  • 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
    ALIMSA