Events

Retiro De Equipo (Recall) de Puritan Bennett 980 Series Ventilator System PB980

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-2016-RN-00089-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-02-03
  • 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-2016-RN-00089-1
  • 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
    There have been reports of issues with the graphical user interface (gui) & loss of primary ventilation. the gui can become unresponsive to touch, but the ventilator continues to operate at existing settings, all real-time waveforms, pressure/volume measurements, alarm functions & the bezel keys remain active. however, users are unable to change ventilator settings/configuration of the display. plus, under certain circumstances there is a loss of primary ventilation capabilities, in which the backup ventilation (buv) design feature is activated. when buv is initiated, high urgency audio & visual alarms are enunciated immediately & cannot be silenced. in some cases, the ventilator subsequently progressed to a ventilator inoperative condition, where the ventilator opens all valves to atmospheric pressure & room air, & ventilation ceases. high urgency audio/visual alarms are enunciated. there have been no reports of adverse health effects or death associated with the above situations.
  • Acción
    Covidien is advising users that the continued use of the affected devices is appropriate. However, the decision to continue to use the affected devices should be made in the context of the individual patient’s clinical condition. If the reported defects occur, the clinical team should transfer the patient to anther ventilator. The manufacturer is working on a service update which will be implemented as soon as it becomes available.

Device

Puritan Bennett 980 Series Ventilator System PB980

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