Events

Safety Alert Or Field Safety Notices for Eleganza Standard (model prefix 1GS) and Deluxe (model prefix 1GL) beds

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 Linet.

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/2011/092
  • Event Number
    CON126110
  • Date
    2011-08-18
  • Event Date Posted
    2011-08-18
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON126110?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
    The manufacturer issued a field safety notice (fsn) for this device on 15 july 2011, but has not had sufficient confirmation from users that they have received and acted on this information. a copy of the fsn is in the appendix of this alert and it is also available on the mhra website. this alert has been issued in support of the manufacturer’s actions.
  • Action
    Ensure that relevant members of staff are aware of the problem. Carry out the actions described in the manufacturer’s FSN, including sending any confirmation requests.Action by:All those using, managing and maintaining hospital beds. In particular: nurses, maintenance staff and contractors.

Device

Eleganza Standard (model prefix 1GS) and Deluxe (model prefix 1GL) beds
  • Model / Serial
  • Product Description
    Eleganza Standard (model prefix 1GS) and Deluxe (model prefix 1GL) beds. Affected serial numbers: Standard: 1739003 – 20053049650 Deluxe: 1752144 – 20053022252
  • Manufacturer
    Linet

Manufacturer

Linet