Events

Retiro De Equipo (Recall) de Philips Sync Cables and Philips ECG Out Cables

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-00900-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-07-21
  • 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-2017-RN-00900-1
  • 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 originally advised of electrical interference via sync cables (tga ref: rc-2014-rn-01291-1), where affected cables were replaced. philips is now advising users to cease using and dispose of sync cables and ecg out cables, as when using a sync cable or ecg out cable with the heartstart mrx or heartstart xl, eft noise may be mistaken as an r-wave. if this occurs when performing synchronised cardioversion, there is a potential for inducing ventricular fibrillation if shocks are synchronised to eft noise instead of the r-wave of the patient’s actual ecg.
  • Acción
    Philips is requesting users read the supplied notice and then: 1. Remove affected sync cables and ECG out cables from service and destroy them, documenting such action on the acknowledgement form, which should be returned to Philips; 2. There are 3 options for the user to synchronise the MRx or XL+ monitor/defibrillators, so the synchronisation function is not lost. In summary, these methods are: -The shock pads ECG can be used for synchronisation. -If the user places or replaced 3 leads ECG pads, the resulting ECG can be used for synchronisation. -The ECG trunk cable can be disconnected from the Philips bedside monitor and connected to the monitor/defibrillator before delivering therapy. For further information, the customer should refer to the Instructions for Use that describe the recommended approach for performing cardioversion.

Device

Philips Sync Cables and Philips ECG Out Cables
  • Modelo / Serial
    Philips Sync Cables and Philips ECG Out CablesPhilips Sync CablesModel Numbers: M1783A and M5526AECG Out CablesModel Number: 989803195641ARTG Number: 95661
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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