Events

Retiro De Equipo (Recall) de IntelliVue MX40 with software revisions B.05, B.06 and B.06.5X

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia 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-2018-RN-00494-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-05-21
  • 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-2018-RN-00494-1
  • 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
    Philips has identified that five warning statements are missing from the instructions for use (ifu) for intellivue mx40 ifu software revisions b.05, b.06 and b.06.5x. if users are unaware of the hazards or limitations described in the missing warning statements, they may not properly assess or provide appropriate treatment to a patient being monitored using an intellivue mx40.These ifus are missing warning statements related to monitoring of patients with pacemakers and the interpretation of qt/qtc measurements that were present in earlier revisions of the ifu. a “warning” alerts users to a potential serious outcome, adverse event or safety hazard. failure to observe a warning may result in death or serious injury to a user or patient.To date, no patient harm has been reported as a result of this issue.
  • Acción
    Phillips will contact affected customers to provide a copy of an Instructions For Use (IFU) Errata. Customers are requested to attach the Errata Sheet to the first page of Chapter 6 of the IFU.

Device

IntelliVue MX40 with software revisions B.05, B.06 and B.06.5X

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA