Press release: Safety concerns over wheelchair when being used as a seat in a motor vehicle

Press release

Date:	16 Feb 2009
Time:	10:30
Subject:	Jazzy, Quantum and LX powered wheelchairs manufactured by Pride Mobility Ltd.
Contact:	Press Office 020 3080 7651 or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189

The Medicines and Healthcare products Regulatory Agency (MHRA) requests users of Jazzy, Quantum and LX battery powered wheelchairs who use their wheelchair as a seat in a vehicle to check if a Transit Securement Package (TSP) has been fitted to their wheelchair by Pride Mobility.

Without a TSP the wheelchair is not intended to be used as a seat in a motor vehicle.

If a TSP has been fitted by Pride Mobility, it is important users contact Pride Mobility Ltd to obtain new instructions for use relating to the TSP and the labelling of the wheelchair.

Pride Mobility has issued field safety notices relating to this issue however they have been unable to trace all users. The manufacturer has also produced a Powerchair Transportation Compatibility Chart highlighting the models intended for use as a seat in a motor vehicle.

Clive Bray, Director of Device Technology and Safety at the MHRA said, “Following investigations by the MHRA, the manufacturer has produced new instructions for use so users are able to ensure they have the correct information to use their wheelchair as a seat in a motor vehicle.

“People should continue to report faulty medical devices 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 to those involved in the provision and maintenance of these wheelchairs, including wheelchair service managers, rehabilitation engineers, maintenance staff and contractors, and patient transport service managers. The MDA includes the Powerchair Transport Compatibility Chart as an appendix.

Notes to Editor

1. The Instructions For Use (IFU) issued with all Pride Mobility powered wheelchairs state they are not intended to be used as a seat in a motor vehicle. This is generally appropriate however, on some models, Pride Mobility has fitted a Transit Securement Package (TSP) before delivery. With this package fitted, the wheelchair can be used as a seat in a motor vehicle provided that an appropriate Wheelchair Tie-down and Occupant Restraint System (WTORS) is used. Pride Mobility did not include this information in the IFU provided with these wheelchairs.
2. Manufacturer details
   Mr Craig Sweetlove
   Pride Mobility Ltd
   Tel: 01869 324600
   Fax: 01869 323070
   E-mail: craig@pride-mobility.co.uk
3. 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
4. For Examples of Transit Securement Packages please see Medical Device Alert MDA/2009/010 at http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON038767
5. For Pride Mobility Powerchair Compatibility Chart please see Medical Device Alert MDA/2009/010 at http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON038767