Events

Safety Alert Or Field Safety Notices for IW900-series infant warmers

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 and 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/2014/048
  • Event Number
    CON491150
  • Date
    2014-12-18
  • Event Date Posted
    2014-12-18
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON491150?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 serious injury to the infant in the warmer the heater head may partially detach due to a manufacturing fault where the nut securing the heater head may break. fisher and paykel healthcare issued a field safety notice (fsn) dated 13 november and provided replacement nuts to customers affected but has not had enough replies to know that users have received and acted on this.
  • Action
    Follow the advice in the FSN to identify the infant warmers and any spare parts that may be affected. Replace affected nuts using the nuts supplied with the FSN. Contact Fisher & Paykel Healthcare if you are not sure about affected devices or how to replace the nut. Complete the FSN response form and return it to Fisher and Paykel Healthcare.

Device

IW900-series infant warmers
  • Model / Serial
  • Product Description
    IW900-series infant warmers. Specific model and lot numbers are affected.
  • Manufacturer
    Fisher and Paykel Healthcare

Manufacturer

Fisher and Paykel Healthcare