Events

Retiro De Equipo (Recall) de Puritan Bennett 840 Ventilator

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-00974-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-09-15
  • 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-00974-1
  • 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
    This is a follow up to an earlier communication (tga ref.: rc-2014-rn-00618-1), for which, if customers were impacted, would have received a visit from a covidien representative to assess whether their puritan bennett 840 ventilator power supply unit (psu) required replacement. some of the affected psus were replaced as part of the routine service of the puritan bennett 840 ventilators by covidien outside of the previous corrective action. the customer reports that initiated these changes to the operator’s manual included the graphical user interface (gui) display screens (both upper and lower) becoming blank or erratic during patient use. this event interferes with the clinician’s ability to view and/or change ventilator setting or clinician-set patient alarm parameters. the ventilator continues to provide respiratory support during these events.
  • Acción
    Covidien is requesting the user to update the Puritan Bennett 840 Ventilator Operator's Manual as per the updated instructions attached with the customer letter in addition to the hardware upgrade they may have received. This action has been closed-out on 18/03/2016.

Device

Puritan Bennett 840 Ventilator

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