Events

Retiro De Equipo (Recall) de Philips Dameca Siesta i TS with an EGM software version lower than 4.0.8 / 7.0.8 (Anaesthesia system)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Proact Medical Systems (Australia) Pty 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-2015-RN-00365-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-04-24
  • 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-2015-RN-00365-1
  • 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
    It has been discovered that the touch screen on dameca siesta i ts machine may malfunction, resulting in the screen freezing or in some cases turning black during usage. this results in the user not being able to operate the machine using the touch screen, current information is not displayed and settings cannot be modified. the machine will stop automatic ventilation and an alarm will sound and the user needs to initiate manual ventilation by activating the emergency fresh-gas flow function (emergency o2) on the siesta i ts and maintaining ventilation by means of the ventilation bag (manual ventilation).The highest concern is the potential loss of ventilation and fresh gas flow. if losing ventilation and fresh gas flow, this will result in the need of manual ventilation with external fresh gas flow and emergency equipment.
  • Acción
    Users are advised that in cases where automatic ventilation stops, the machine should be restarted (while manually ventilating the patient) and then taken back into normal usage again (return to automatic ventilation and fresh-gas delivery by the electronic gas mixer) after the machine has restarted. Users are also advised to check their existing machine’s version. If EGM software version is lower than 4.0.8/7.0.8 and the problem arises a technician visit will be arranged to upgrade the software. This action has been closed-out on 15/02/2017.

Device

Philips Dameca Siesta i TS with an EGM software version lower than 4.0.8 / 7.0.8 (Anaesthesia sys...

Manufacturer

Proact Medical Systems (Australia) Pty Ltd