Events

Safety Alert Or Field Safety Notices for Babytherm infant warmers and open infant care units for newborns

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 Draeger Medical.

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/2014/041
  • Event Number
    CON467380
  • Date
    2014-10-21
  • Event Date Posted
    2014-10-21
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON467380?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 baby falling out of the device. failure to follow the instructions for use for inserting the inner safety panels and locking the outer safety side panels may result in them opening unexpectedly. draeger sent a field safety notice to its customers in august 2014 but hasn’t had enough replies to know if users have received and acted upon this information.
  • Action
    Identify affected devices. Ensure users read the important information in the Field Safety Notice (FSN) and follow the instructions (see appendix) to ensure that the inner safety panels are in place and the outer side panels are securely locked into position. If the locking mechanism is not functioning, contact Draeger. Complete the acknowledgement sheet you received with the FSN and return it to Draeger.

Device

Babytherm infant warmers and open infant care units for newborns
  • Model / Serial
  • Product Description
    Babytherm infant warmers and open infant care units for newborns. Model numbers: 8004, 8010 and 8000WB. This device is an open care unit for warming premature babies, neonates and infants with a body weight of up to 8 kg.
  • Manufacturer
    Draeger Medical

Manufacturer

Draeger Medical