Events

Safety Alert Or Field Safety Notices for Powered wheelchairs: Harrier range

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 Invacare.

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/2012/060
  • Event Number
    CON180656
  • Date
    2012-08-22
  • Event Date Posted
    2012-08-22
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON180656?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 drive wheel may detach from the wheelchair, as a result of being incorrectly refitted due to inadequate service/maintenance instructions in the technical manual.  the manufacturer published a field safety notice (fsn) in april 2012 to notify technicians of the revised removal / refitting procedure. the manufacturer has not received sufficient confirmation that this fsn had been received and acted upon.
  • Action
    Ensure that technicians responsible for maintenance of Harrier wheelchairs: have a copy of the amended procedure – this is attached to the Field Safety Notice, and can also be downloaded from the Invacare website (external link) are aware of the revised guidance regarding removal and refitting of the drive wheel inform Invacare that the FSN has been received and that the revised procedure has been reviewed and understood.

Device

Powered wheelchairs: Harrier range
  • Model / Serial
  • Product Description
    Powered wheelchairs. All chairs in the Harrier range.
  • Manufacturer
    Invacare

Manufacturer

Invacare