MHRA device alert: 'Infinity' wheelchair cushions
(Monday, 12th May 2003)

Problem with fire retardancy (REF: MHRA)

Since the initial product launch in March 2000, Invacare Limited have introduced changes to the materials used in the construction of the Infinity range of seat cushions. At the time of introduction of the materials, no tests were carried out to verify that they met reasonable standards of fire retardancy. Subsequent testing has found that the cushions will not self extinguish when exposed to an open flame.

Although to date no actual incidents have been reported to MHRA, persons using these products may be at risk.

The manufacturer has devised a solution to remove the risk for those cushions already supplied, which involves the fitting of a flameproof interliner between the two existing covers. Invacare will provide these free of charge to all existing customers.

Invacare Limited are also attempting to notify all customers that they have supplied with Infinity seat cushions by means of a safety bulletin. However, this may not reach all existing users where local records are incomplete or the cushion has been issued to a new user.

The company will ensure that materials used in future supplies meet appropriate levels of resistance to ignition, to remove the need for an interliner.

This notice should be brought to the attention of all those involved with the provision and supply and record keeping of this type of wheelchair cushion.

The MHRA recommends the following action be taken:

Trace all Infinity wheelchair seat cushions manufactured by Invacare Limited and supplied since March 2000
Obtain a K1 flame resistant interliner from Invacare Limited and fit between the outer and inner covers of the existing cushions, in line with the fitting instructions supplied with a new the interliner.
Enquiries to the manufacturer should be addressed to: Kevin Humphries, Director of Technical Services, Invacare Ltd, South Road, Bridgend Industrial Estate, Bridgend, Mid Glamorgan, CF31 3PY. Tel: 01656 753270. Fax: 01656 649016.

Enquiries to the MHRA should quote reference number MDA/2003/013 (20030331.014-2) and be addressed to: Mike Dignan or Alan Lynch, MHRA, Wheeled Mobility and Seating Centre, 241 Bristol Avenue, Bispham, Blackpool FY2 0BR. Tel: 01253 596000. Fax: 01253 596177

REF: Medicines and Healthcare products Regulatory Agency, Hannibal House, Elephant and Castle, London SE1 6TQ

Medicines and Healthcare products Regulatory Agency website
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