Events

Retiro De Equipo (Recall) de F & P SleepStyle CPAP Device Devices using V1.1.0 firmware

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-2018-RN-00250-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2018-03-29
  • 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-00250-1
  • 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 healthcare has identified a firmware anomaly which prevents the fisher & paykel sleepstyle from recording clinical data, and may delay remote prescription changes if the device is continually powered for 20-50 days. this time frame may vary depending on the number and length of therapy sessions. the firmware anomaly does not prevent the ongoing delivery of currently prescribes setting and therapy does not affect any other functions of the device. only devices with v1.1.0 firmware are affected.To date, no complaints resulting in injury have been received relating to this issue.
  • Acción
    Fisher and Paykel will be contacting distributors, hospitals and retailers to arrange for hardware upgrade to be installed in affected units. For devices currently used in a home setting, this action does not impact products with activated modem capabilities. For affected product without modems, have non-activated modems or modems out of service, continuous data recording can be ensured by reminding users to follow instructions in the SleepStyle Use and Care guide to unplug and clean the device every 7 days.

Device

F & P SleepStyle CPAP Device Devices using V1.1.0 firmware
  • Modelo / Serial
    F & P SleepStyle CPAP Device Devices using V1.1.0 firmwareModel Number; SPSAAA, SPSCAABatch Numbers: SPSAAA: 2100199626 - 2100401417SPSCAA: 2100194431 - 2100302650ARGT Number: 227979 (Fisher & Paykel Healthcare - OSA CPAP Therapy devices - Home CPAP unit)
  • Manufacturer
    Fisher & Paykel Healthcare Pty Ltd

Manufacturer

Fisher & Paykel Healthcare Pty Ltd