Events

Retiro De Equipo (Recall) de Astral 100 and 150 ventilators

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-2017-RN-00762-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-07-19
  • 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-00762-1
  • 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 number of reports about the performance of the internal battery, where false activation of a fuse leads to shut down of the internal battery. prior to the issue occurring, one or more of the following alarms were activated: battery inoperable, power fault / no charging, device overheating. if the device is running on external power then ventilation will continue. if the device is not running on external power, or external power is removed, then ventilation will stop with activation of the total power fail alarm. reconnection to external power will enable ventilation to recommence.When ventilators use the internal battery as the sole power source, any performance issue with the battery could lead to cessation of therapy. in these cases, ventilator-dependent patients may be at risk if no urgent action is taken to restore power or switch to back-up ventilation. there have been no reports of this issue in australia to date, nor any adverse health effects.
  • Acción
    ResMed is providing a Clinical Guide addendum that is to be kept with existing Clinical Guides that includes the following warning: The internal battery is NOT intended to serve as a primary power source. It should only be used briefly when necessary; for example, when changing power sources, or when other sources are temporarily unavailable. In addition, users and carers are to continue to follow all patient and device information in the Astral User and Clinical Guides, in particular the following warnings: - For ventilator-dependent patients, always have alternate ventilation equipment available, such as a back-up ventilator, manual resuscitator or similar device. Failure to do so may result in patient injury or death. - Ventilator-dependent patients should be continuously monitored by qualified personnel or adequately trained carers. These personnel and carers must be capable of taking the necessary corrective action in the event of a ventilator alarm or malfunction.

Device

Astral 100 and 150 ventilators
  • Modelo / Serial
    Astral 100 and 150 ventilatorsAll Astral External BatteriesAll Astral Battery PacksARTG Numbers: 219429 and 158756
  • Manufacturer
    Resmed Limited

Manufacturer

Resmed Limited