Important Safety Alerts

The Australia Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning power wheelchairs manufactured by Invacare Corporation. The following products are affected:

• Invacare Power wheelchairs with SPJ+ Joysticks and MK6i Driver Controls (excluding all ASL, Sip-n-Puff, and Switch control systems)
• Invacare Power wheelchairs with SPJ+ Joystick models manufactured between 9 September 2009 to 21 March 2013
• Invacare Power wheelchairs with MK6i Driver Controls (excluding all ASL, Sip-n-Puff and Switch control systems) manufactured between 1 October 2006 to 21 March 2013

Invacare has identified a defect in a small percentage of crimped wire connections in certain joysticks which could result in oxidation leading to the slowdown of wheelchair speed performance over time. In a very small percentage of instances, the power wheelchair may slow down relative to the commanded speed and then recover, creating an unintended acceleration. The unintended acceleration due to this defect has resulted in a consumer's power wheelchair running into objects, which can lead to bruising, pinched fingers, and pinched hands.

Invacare is providing distributors with two options to correct the affected joystick:

• Invacare will supply the distributors with the correction kit for each affected joystick, with instructions on how to return the affected joysticks to Invacare.
• Invacare will engage a third party to complete the correction. Distributors are required to provide the details for end users to the third party in order to correct the affected joysticks. Invacare will correspond with end users directly if this option is selected.

For details, please visit the following TGA website:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00977-1

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 7 October 2013