Events

Safety Alert Or Field Safety Notices for SleepStyle CPAP devices

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Fisher & Paykel Healthcare.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2010/076
  • Event Number
    CON094175
  • Date
    2010-09-29
  • Event Date Posted
    2010-09-29
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON094175?tabName=allTabs
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    Risk of cessation of therapy due to deterioration of power cord.Fisher & paykel healthcare has received reports of deterioration in the connectors of power cords supplied with their cpap flow generators.A power cord that deteriorates will stop working because of a disconnection in the internal wiring, which may lead to arcing and ultimately could cause a melt or breach of the outer cord sheath (insulation); this may arise near the connector that plugs into the cpap unit.
  • Action
    Ensure that all users, including patients at home, are aware of the manufacturer’s Field Safety Notice. Identify affected devices. The model number and lot number are located on the bottom of the CPAP device. Remove the water chamber or empty it before viewing the bottom of the device. Contact the manufacturer to arrange for a replacement power cord. In the interim users should continue with their CPAP therapy.

Device

SleepStyle CPAP devices
  • Model / Serial
  • Product Description
    SleepStyle CPAP devices. Manufactured by Fisher & Paykel Healthcare. Specific model and lot numbers are affected. This device is used for the treatment of obstructive sleep apnoea and delivers continuous positive airway pressure (CPAP) to assist with a patient’s breathing during sleep. The device is for use by adult patients at home or in a sleep laboratory. The model numbers of affected devices are: HC23XAEK and HC23XMEK HC24XAEK and HC24XMEK HC254AEK and HC254MEK HC60XAEK and HC60XMEK (Where X is a number). The relevant LOT numbers are those up to and including 091122. The image below shows where the model and lot number are located on the device label. CPAPs manufactured with lot numbers higher than 091122 have a different power cord and are not subject to this product replacement.
  • Manufacturer
    Fisher & Paykel Healthcare

Manufacturer

Fisher & Paykel Healthcare