Events

Retiro De Equipo (Recall) de Philips IntelliVue Neuromuscular Transmission (NMT) Patient Cables (Used with Philips IntelliVue NMT Module 865383 and IntelliVue Patient Monitors)

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-2017-RN-00629-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-05-19
  • 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-2017-RN-00629-1
  • 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
    Investigations conducted by philips subsequent to customer complaints have revealed that a small number of intellivue neuromuscular transmission (nmt) patient cables may contain a localised isolation defect in the shielding of the acceleration sensor housing. this manufacturing defect may cause localised heating due to an unintended current flow between the acceleration sensor housing attached to the patient thumb and the nmt stimulation electrode connection attached to the wrist of the same hand. using a defective nmt patient cable on a patient under anaesthesia who receives repeated nmt stimulations during a procedure may result in a localised skin burn of up to several millimetres in diameter.
  • Acción
    Philips is requesting customers to identify all affected cables by checking their inventory for NMT patient cables that bear the CE mark with the suffix "0366". The affected stock is to be removed from inventory and quarantined. Customers will be contacted by a Philips Healthcare representative or an authorised service provider to arrange for a visit to replace the affected cables.

Device

Philips IntelliVue Neuromuscular Transmission (NMT) Patient Cables (Used with Philips IntelliVue ...
  • Modelo / Serial
    Philips IntelliVue Neuromuscular Transmission (NMT) Patient Cables (Used with Philips IntelliVue NMT Module 865383 and IntelliVue Patient Monitors)Philips IntelliVue NMT Patient CablesModel: 989803174581Cable also supplied in Philips IntelliVue NMT Module, Product Option #K01, Model : 865383 #K01 Cables that have CE Mark with suffix 0366 ARTG Number: 202378
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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