Events

Retiro De Equipo (Recall) de AIRVO 2 / myAIRVO 2 HumidifierAIRVO 2 Humidifier

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Fisher & Paykel Healthcare 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-2016-RN-00729-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-06-08
  • 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-00729-1
  • 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
    Fisher & paykel has updated the airvo 2 / myairvo 2 user instructions to include a check that the speaker is audible prior to each patient use in order to ensure the speaker is functioning.
  • Acción
    Fisher & Paykel are advising users that the AIRVO 2 / myAIRVO 2 User Instructions have been updated to include a warning for the user to check speaker functionality before each patient use, using the steps in the User Instructions. First turn the unit on and then remove the heated breathing tube. The user should see the “check tube” visual signal and hear the speaker signal. If either signal is absent, users are advised not to use the unit and contact their Fisher & Paykel representative to arrange for a replacement device.

Device

AIRVO 2 / myAIRVO 2 HumidifierAIRVO 2 Humidifier
  • Modelo / Serial
    AIRVO 2 / myAIRVO 2 HumidifierAIRVO 2 HumidifierModel Number: PT101XXmyAIRVO 2 HumidifierModel Number: PT100XXAffected Serial Numbers: 120521YYYYYY – 160605YYYYYYARTG Number: 177298
  • Manufacturer
    Fisher & Paykel Healthcare Pty Ltd

Manufacturer

Fisher & Paykel Healthcare Pty Ltd