Retiro De Equipo (Recall) de Capnostream 20p Patient Monitors - battery pack (used for combined capnograph/pulse oximeter monitor)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Covidien Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Covidien respiratory and monitoring solutions, now a part of medtronic, is issuing a recall for the battery pack used in oridion labelled capnostream20p patient monitors. the scope of this recall includes battery packs that were manufactured between april 2014 and february 2016. the recall includes battery packs included with the monitors and spare replacement parts purchased separate from the monitor. this recall is due to a supplier defect in battery manufacturing that may increase the risk of thermal damage to the battery pack. there has been one report involving a fire resulting in smoke inhalation and minor burns to a user.
  • Acción
    Medtronic is advising users to identify, remove and appropriately dispose of affected battery packs using the instructions provided. Alternatively, contact Medtronic with assistance with the disposal. Once the batteries are removed, the Patient Monitor must be connected to AC power and can no longer be used for intra-hospital transport of patients until replacement batteries are provided. This action has been closed-out on 28/02/2017.


  • Modelo / Serial
    Capnostream 20p Patient Monitors - battery pack (used for combined capnograph/pulse oximeter monitor)INTL Capnostream 20P w/prntrProduct Code: CS08658-01INTL Capnostream 20P N X1Product Code: CS08652-01Batteries manufactured between April 2014 and February 2016ARTG Number: 207165
  • 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