Events

Retiro De Equipo (Recall) de Transpac 4 Disposable Pressure Transducer Monitoring Kit

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-00015-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-01-06
  • 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-00015-1
  • 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
    Certain lots of the transpac 4 disposable pressure transducer monitoring kit may have the potential to leak or potentially introduce small amounts of air into the line. this could result in potential harm to the patient due to blood loss, introduction of air into the line or contamination of intravenous fluid. there is also potential harm to the user as a result of exposure to blood borne pathogens.
  • Acción
    Philips is advising users to discontinue use of affected products and to check their inventory for affected stock. Affected stock is to be quarantined and users are requested to contact Philips prior to returning the affected products in order to receive a credit. This action has been closed-out on 01/03/2018.

Device

Transpac 4 Disposable Pressure Transducer Monitoring Kit
  • Modelo / Serial
    Transpac 4 Disposable Pressure Transducer Monitoring KitProduct Number: 989803177901Lot Numbers: 3239500, 3247905Product Number: 989803194641Lot Number: 3258299ARTG Number: 197576
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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