Events

Field Safety Notices about K- Series, Competition, Compact, Compact – Hemi Combi Drive, Kid and Ultra Light Wheelchairs

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland 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
    Field Safety Notice
  • Event Number
    SN2006(08)
  • Date
    2006-11-20
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/k--series-competition-compact-compact-hemi-combi-drive-kid-and-ultra-light-wheelchairs&id=a494f825-9782-6eee-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
    The wheelchair seat covers manufactured by invacare between february and october 2003 were supplied with a covering material, which did not meet the requirements for flammability defined by the manufacturer.
  • Action
    Ensure that the purchaser and prescribers of these devices within your healthcare institution:   1. Identify all K-series, competition, compact, compact-hemi drive, kid and Ultra light seat covers that were supplied to your healthcare institution in 2003  2. Arrange with your supplier (Invacare Ireland or Lifestyle Mobility) to check the seat cover material.  The inside of the non-flame retardant cover is black while the inside of the flame retardant cover is grey.  3. Ensure that all affected seat covers are replaced with new covers.

Device

K- Series, Competition, Compact, Compact – Hemi Combi Drive, Kid and Ultra Light Wheelchairs
  • Model / Serial
  • Product Description
    K- Series, Competition, Compact, Compact – Hemi Combi Drive, Kid and Ultra Light Wheelchairs
  • Manufacturer
    Invacare

Manufacturer

Invacare