Events

Recall of F & P SleepStyle CPAP Device Devices using V1.1.0 firmware

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Fisher & Paykel Healthcare Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2018-RN-00250-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2018-03-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00250-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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
  • Model / 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