Events

Retiro De Equipo (Recall) de Vadi Heater

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por AHC Solutions 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-2018-RN-00041-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-01-15
  • 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-2018-RN-00041-1
  • 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
    Ahs solutions p/l has been made aware of an issue regarding overheating of vadi heater vh220 causing shrinkage of the filter due to dysfunction of the cut-off switch. the root cause analysis found that the dysfunction of the switch is due to the distance from the tape to glue the switch to the heating scroll not being attached closely enough. as a result, there is a gap between switch and aluminium heating scroll, which, after a long term use, can damage the switch. the damaged switch will therefore be unable to control the temperature, causing overheating which deforms the filter.
  • Acción
    AHC Solutions is advising users to dispose of VH220 heaters that are currently in use. Customers will be provided with replacement heaters.

Device

Vadi Heater
  • Modelo / Serial
    Vadi Heater Part Number: VH220ARTG Number: 212166 (AHC Solutions Pty Ltd - Filter, ventilator)
  • Manufacturer
    AHC Solutions Pty Ltd

Manufacturer

AHC Solutions Pty Ltd