Events

Retiro De Equipo (Recall) de Astral 100 and Astral150 Ventilators - Degraded Battery Pack

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Resmed Limited.

¿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-2016-RN-01074-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-08-16
  • 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-2016-RN-01074-1
  • 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
    Resmed has received a small number of reports regarding the performance of the internal battery in the astral ventilator. in these reports, an internal electrical issue has led to ventilation ceasing without either the low battery alarm or the critically low battery alarm being activated. in all of these reported cases the “total power failure” alarm activated as intended.Under these circumstances, ventilator dependent patients may be at risk if no urgent action is taken to restore power or switch to back-up ventilation. the risk of this occurring is increased if the internal battery has been charged a high number of times. this fault has also been reported with the astral external battery however, there have been no reports of cessation of ventilation when the astral external battery is used.It remains safe to continue using astral ventilators, provided patients/carers follow the precautions provided. there have been no reports of adverse health effects as a result of this issue.
  • Acción
    ResMed is providing users with work around instructions to follow as an interim measure. Patients and carers are advised to connect the ventilator to AC power whenever possible, and to use an external power supply where necessary. It is recommended that ventilator dependant patients have alternative ventilation equipment available at all times. All ventilators with an affected battery pack should have their internal batteries replaced by no later than 1 December 2016. For further information, please see https://www.tga.gov.au/alert/astral-100-and-astral-150-ventilators-0

Device

Astral 100 and Astral150 Ventilators - Degraded Battery Pack
  • Modelo / Serial
    Astral 100 and Astral150 Ventilators - Degraded Battery Pack Serial Numbers below: 22161332346 for Astral ventilators, and 20160748193 for Astral external batteriesARTG Numbers: 219429, 158756
  • Manufacturer
    Resmed Limited

Manufacturer

Resmed Limited