Events

Retiro De Equipo (Recall) de Philips M1783A and M5526A 12 Pin Sync 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-2014-RN-01291-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-12-10
  • 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-01291-1
  • 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
    The following problems were found during internal testing:if electrical fast transits (eft) noise is injected into the monitor/defibrillator via ac mains power, and the monitor/defibrillator is connected to and receiving ecg signals from an auxiliary bedside monitor with an m1783a/m5526a 12 pin sync cable (8/24 feet) via the monitor’s ecg out port, then:1. when using a sync cable with the heartstart mrx or heartstart xl, eft noise can be mistaken as an r-wave. if this occurs when performing synchronized cardioversion, there is a potential for inducing ventricular fibrillation if shocks are synchronized to eft noise instead of the patient’s actual r-wave. 2. when using a sync cable with the heartstart xl+, eft noise can disable ecg monitoring, and potentially interrupt demand mode pacing, leading to a possible delay in therapy. a power cycle is required to resume ecg monitoring, however, fixed mode pacing is not impacted by this issue.
  • Acción
    Philips will replace all affected sync cables with a new sync cable free of charge. A Philips Healthcare representative will contact customers with affected devices to arrange for a replacement. This action has been closed-out on 05/12/2016.

Device

Philips M1783A and M5526A 12 Pin Sync Cables

Manufacturer

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