Events

Retiro De Equipo (Recall) de Esprit V1000 and Esprit/V200 Conversion VentilatorRespironics

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-01245-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-11-21
  • 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-2014-RN-01245-1
  • 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
    If the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (pcba) and short to ground which may prevent the ventilator to switch to battery power if ac power is disrupted. a high urgency audible alarm will sound alerting medical personnel of the loss of power. in the absence of ac power, failure of battery power will cause loss of ventilator support which could result in hypercarbia or hypoxemia.
  • Acción
    Philips is advising their customers to carry out a Power Fail Alarm Test as per the Operators Manual. If AC power is disrupted and the ventilator cannot switch to battery operation, a High Urgency alarm will sound and the patient must be supported with another means of life support ventilation. A new fan installation hardware kit will be installed on affected units. A Philips Field Service Engineer will be contacting customers to schedule the installation at no-cost. This action has been closed-out on 12/08/2016.

Device

Esprit V1000 and Esprit/V200 Conversion VentilatorRespironics
  • Modelo / Serial
    Esprit V1000 and Esprit/V200 Conversion VentilatorRespironics Part Numbers: 701-01000-00, C701-01000-00, DU701-01000-00, U701-01000-00Philips Part numbers : 989805611721, 989805643301, 989805612621, 989805613441ARTG Number: 134845
  • Clasificación del producto
    Anesthesiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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