Events

Retiro De Equipo (Recall) de Puritan Bennett 840 Ventilator and 700 Series (740 and 760)

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
    Recall
  • ID del evento
    RC-2014-RN-00093-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-01-24
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00093-1
  • 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
    The oxygen sensor for the ventilators has a life of one (1) year from date of manufacture of the sensor, depending on the operating conditions. conflicting information was provided to puritan bennett 840 ventilator customers in a labelling addendum stating that the oxygen sensor should be replaced every two years. if a sensor becomes non-functional during use and cannot be recalibrated, an external oxygen monitoring device with oxygen alarm capability may be required to monitor the supplied level of oxygen from the ventilator and to provide appropriate alarms. a non-functional o2 sensor does not affect the concentration of oxygen delivered from the ventilator and does not control the flow of gases.
  • Acción
    Covidien is providing updated labelling to clarify the operational life of the oxygen sensor used in the Puritan Bennett 840 and 700 series ventilators. Coviden is also advising users that if a sensor becomes non-functional and facility protocol requires transfer of a patient to an alternate ventilator, the patient must be clinically evaluated to determine the best conditions for transfer to reduce risk to the patient.

Device

Puritan Bennett 840 Ventilator and 700 Series (740 and 760)
  • Modelo / Serial
    Puritan Bennett 840 Ventilator and 700 Series (740 and 760) Ventilators Oxygen Sensor Part Number for 840 Ventilator: 4-072214-00Oxygen Sensor Part Number for 700 Series Ventilator: G-062010-00ARTG Number: 182309
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien Pty 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
    DHTGA