Events

Safety Alert Or Field Safety Notices for Ibis Comfort wheelchair

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 Handicare B.V.

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/2013/049
  • Event Number
    CON295475
  • Date
    2013-07-04
  • Event Date Posted
    2013-07-04
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON295475?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
    Handicare has identified a quality issue with the tilt adjustment on ibis comfort wheelchairs. the upper hinge block component used in the tilt mechanism may break. this could cause the seat unit to tip backwards unexpectedly. there is a field safety notice for uk customers.
  • Action
    Identify all affected Ibis Comfort wheelchairs. Contact Handicare or your dealership to arrange exchange of the tilt adjustment component (upper hinge blocks). Dealers should contact Handicare for the instructions for changing the hinge blocks. Dealers should inform Handicare when the component has been replaced.

Device

Ibis Comfort wheelchair
  • Model / Serial
  • Product Description
    Ibis Comfort wheelchair. Specific serial numbers of chairs manufactured from 29 January to 12 April 2013 inclusive. Photograph showing location of affected hinge block Photograph showing old and new style hinge blocks.
  • Manufacturer
    Handicare B.V

Manufacturer

Handicare B.V