Events

Field Safety Notices about Quickie Neon Swing-Away Wheelchairs

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Sunrise 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
    Field Safety Notice
  • Event Number
    SN2011(32)
  • Date
    2011-12-09
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/quickie-neon-swing-away-wheelchairs&id=b380f825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Extra notes in the data
  • Reason
    It has come to sunrise medical’s attention through post-market surveillance activities that a small number of upper frame tubes that support the backrest have failed on the quickie neon swing-away wheelchair. there is the potential for frames to fail and users could potentially fall backwards resulting in serious injury.
  • Action
    The IMB advises that users:  1. Ensure the appropriate personnel are made aware of this notice.  2. Identify the location of all affected wheelchairs.  3. If you / your institution have affected wheelchairs, please follow the manufacturer’s recommendations as outlined in the attached FSN and ensure that the corrective action is completed on all affected medical devices.

Device

Quickie Neon Swing-Away Wheelchairs
  • Model / Serial
  • Product Description
    Quickie Neon Swing-Away Wheelchairs
  • Manufacturer
    Sunrise Medical

Manufacturer

Sunrise Medical