Invacare power wheelchairs
Update
21 April 2015
As advised in the 10 December 2013 update below, Invacare Australia has implemented a systematic approach to remediate the affected Invacare power wheelchair models due to the limited availability of replacement joysticks. Invacare has advised the TGA that the majority of these customers have been contacted and their affected wheelchairs have been, or will be, repaired. However, Invacare and its distributors have not been able to contact all customers potentially affected by the joystick issue and nationwide advertisements have been published to alert these consumers of the recall for product correction.
Update
10 December 2013
On 11 October 2013, the TGA published a safety alert regarding a recall for product correction of some models of Invacare power wheelchairs due to potentially faulty control joysticks (see below for details). The sponsor, Invacare Australia, subsequently advised TGA that it has not been able to secure enough replacement joysticks to correct all potentially affected power wheelchairs immediately. A sufficient supply of replacement joysticks is expected to become available in March 2014. In consultation with the TGA, Invacare Australia has temporarily limited the scope of its corrective action program to ensure it retains stock to be able to repair wheelchairs that actually exhibit faults. The full recall will resume once sufficient replacement parts become available.
Invacare power wheelchairs
Recall for product correction - potential for reduced speed and unintended acceleration
11 October 2013
Consumers and health professionals are advised that Invacare Australia, in consultation with the TGA, is undertaking a recall for product correction for some models of Invacare power wheelchairs.
It has been identified that there is a wiring defect in the joystick of a small number of wheelchairs which may result in the following issues:
- the power wheelchair may slow down relative to the selected speed and not recover, driving at a reduced speed
- the power wheelchair may slow down relative to the selected speed and then recover, creating an unintended acceleration.
If you experience unintended acceleration, you should immediately release the joystick to enable the power wheelchair to slow to a stop (as per instructions in the user's manual). See the sections 'Information for consumers' and 'Information for health professionals' below for more information.
Affected power wheelchair models are determined by the type of joystick and the date the power wheelchair was manufactured by Invacare. The affected models have:
- Invacare SPJ+ joysticks on Invacare power wheelchair models manufactured between 9 September 2009 and 21 March 2013
- MK6i joysticks or driver controls (excluding all ASL, Sip-n-Puff, and Switch control systems) on Invacare power wheelchair models manufactured between 1 October 2006 and 21 March 2013
Invacare SPJ+ and MPJ+ joysticks comprise more than 95% of those affected by the recall (see images).
Affected serial numbers and where to find them
- Serial numbers of affected wheelchairs fall in the range 06JXXXXXXX to 13CXXXXXXX. The first two digits represent the year, the first letter represents the month (A=January, B=February etc).
- Serial numbers can be located in varying places on different models of Invacare power wheelchairs.
- Invacare wheelchair serial number location chart (pdf,129kb)
Information for consumers
If you experience any of the unintended acceleration issues described above, or have any questions, you should contact Invacare Australia Customer Services on 1800 460 460 to arrange for a replacement joystick.
Invacare or a local distributor has contacted all affected power wheelchair users providing more information about this issue including details on how to arrange for replacement of an affected joystick and the timeframe involved.
If a user experiences any of the issues described above they should exercise caution when navigating their chair in confined spaces or within areas that may present a risk of hazard (for example, when on an elevated pathway or incline or decline ramp, near a stairwell, or on roadways).
The identified issues are rare and to date reported incidents have resulted in minor injuries only. However, if you experience unintended acceleration, you should immediately release the joystick to enable the power wheelchair to slow to a stop (as per instructions in the user's manual).
Information for all health professionals
Invacare or a local distributor has contacted all affected power wheelchair users providing more information about this issue including details on how to arrange for replacement of an affected joystick and the timeframe involved.
If you are treating a patient who uses an affected Invacare power wheelchair, please make sure they are aware of this issue.
Reassure patients that the issues are rare and to date reported incidents have resulted in minor injuries only. However, if they do experience unintended acceleration, they should immediately release the joystick to enable the power wheelchair to slow to a stop (as per instructions in the user's manual) and contact Invacare Australia Customer Services on 1800 460 460 to arrange for a replacement joystick. If a patient has experienced this problem they should exercise caution when navigating their chair in confined spaces or within areas that may present a risk of hazard (for example, when on an elevated pathway or incline or decline ramp, near a stairwell, or on roadways).
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.