Events

Retiro De Equipo (Recall) de Vapotherm Disposable Patient Circuit System (Delivers high flow humidified gases via a nasal cannula or other patient interface)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Surgical Specialties 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-2014-RN-00916-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-08-22
  • 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-00916-1
  • 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
    Vapotherm inc. has received a small number of complaints involving a defect in the disposable patient circuit delivery tube. the defect allows water to leak into the centre lumen of the delivery tube, the gas line to the patient. the fault condition is easily detectable and typically occurs while the device is coming up to the set temperature and is easily visible when following the precision flow instructions for use, which requires that the cannula be connected to the patient only after the set temperature is reached.
  • Acción
    Customers are asked to check their stock immediately to determine if they have any affected product. Customers are advised to return the affected stock to Surgical Specialties Pty Ltd. This action has been closed-out on 10/05/2017.

Device

Vapotherm Disposable Patient Circuit System (Delivers high flow humidified gases via a nasal cann...
  • Modelo / Serial
    Vapotherm Disposable Patient Circuit System (Delivers high flow humidified gases via a nasal cannula or other patient interface)Part Numbers: PF-DPC-High, PF-DPC-Low Lot Numbers: HF1402035, HF1404043, LF1402030, LF1405023ARTG Number: 147794
  • Manufacturer
    Surgical Specialties Pty Ltd

Manufacturer

Surgical Specialties Pty Ltd