Press release: Medical devices regulator issues alert over wheelchairs

Press release

Date:	29 Oct 2008
Time:	12:00
Subject:	Breezy Moonlite manual wheelchairs
Contact:	Press Office 020 3080 7651 or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189

Users and buyers of Breezy Moonlite manual wheelchairs manufactured by Sunrise Medical Ltd are being urged to be vigilant by the Medicines and Healthcare products Regulatory Agency (MHRA) over safety concerns with the wheelchair’s backrest. The issue concerns sudden failure of the backrest hinge leading to the wheelchair user or the person pushing the wheelchair to fall and injure themselves.

All Breezy Moonlite manual wheelchairs manufactured before 08 August 2008, with serial numbers preceding ML18T08081033, are affected. These wheelchairs were supplied exclusively to the UK market. Sunrise Medical are now to provide free of charge replacement backrest hinges that must be fitted.

Clive Bray, Director of Device Technology and Safety at the MHRA said, “We have received two incident reports where the backrest hinge has suddenly failed because it is not strong enough. People are advised to stop using these wheelchairs until a replacement kit has been fitted by the manufacturer to minimise the potential for injury.

“People can report any faulty medical device to the MHRA by calling our Adverse Incident Hotline on 0207 084 3080 or via our website at www.mhra.gov.uk.”

A Medical Device Alert (MDA) has also been issued today to those involved in the provision, prescription and use of these wheelchairs. These include wheelchair service managers, rehabilitation engineers, occupational therapists and maintenance staff/contractors.

 

Notes to Editor

1. People can contact Sunrise Medical Ltd on 01384 446 666 to obtain a replacement backrest kit and arrange for it to be fitted.
2. One incident report received by the MHRA concerned an actual minor injury where the person fell backwards out of the wheelchair. The second report was a near miss – the person had to stop the wheelchair user from falling.
3. Sunrise Medical Ltd has distributed several thousands of these chairs. An unknown number have been sold through retail outlets.
4. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone –the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action. www.mhra.gov.uk