Events

Retiro De Equipo (Recall) de NeoMode software used on Puritan Bennett 980 Series (PB980) Universal Ventilator System

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-2015-RN-00676-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-07-21
  • 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-2015-RN-00676-1
  • 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 in which tidal volumes reaching patients were lower than set tidal volumes in neonatal volume control plus (vc+) mode with active humidification. this situation may potentially lead to respiratory compromise if not recognised. there have been no serious injuries or deaths related to these reports. covidien’s investigation has identified a software anomaly that contributes to this volume delivery issue in neonatal vc+ mode. this issue has not been observed during neonatal pressure control ventilation, or with paediatric or adult modes of ventilation.
  • Acción
    Covidien will develop and implement a software update for the universal models of ventilators with NeoMode capability. Until that time, Covidien will disable the clinician’s ability to use NeoMode in the PB980 ventilator. A service engineer will be in contact with hospitals to coordinate this process.

Device

NeoMode software used on Puritan Bennett 980 Series (PB980) Universal Ventilator System
  • Modelo / Serial
    NeoMode software used on Puritan Bennett 980 Series (PB980) Universal Ventilator SystemARTG Number: 221416
  • Clasificación del producto
    Anesthesiology Devices
  • 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