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Permobil powered wheelchairs - Corpus II seating system
Recall for product correction - potential for injury due to breakage of the seating system
Consumers and health professionals are advised that Permobil Australia, in consultation with the TGA, is undertaking a recall for product correction of specific Permobil powered wheelchairs with Corpus II seating systems.
- It has been identified that a potential failure of the top plate can result in the seating system separating from its base. The top plate is a component that connects the seating system to the base by a series of welds.
- If this occurs, the seating system and the user could fall from the base, potentially leading to injury.
- As of 12 October 2017, a total of 71 cases of this fault have been reported, with three cases involving serious injury, such as cuts and broken bones.
Permobil Australia's records show that a total of 11 individual Permobil powered wheelchairs that might be affected by this issue have been supplied in Australia.
The serial numbers and model details of those wheelchairs are:
|2557000160||C500||Corpus II LR|
|2557000185||C500||Corpus II LR|
Permobil Australia is sending distributors repair kits to address this problem. In the meantime, distributors are being instructed to contact affected users and arrange to perform an inspection of the top plate assembly for signs of cracking. If no signs of cracking are visible, the wheelchair can continue to be used in accordance with the owner's manual until the repairs are completed. If signs of cracking are evident, the wheelchair must not be used until the repairs are completed.
Cases of cracking are expected to be rare. However, if it does occur, Permobil Australia will assist with providing a temporary solution to allow the user to remain mobile during the time between inspection and repair of the affected wheelchair.
Information for consumers
Permobil Australia has contacted distributors to provide further information about this issue, including instructions to contact the potentially affected users.
If you or someone you provide care for uses a Permobil powered wheelchair, check it against the list of serial numbers and model details above to see if it is affected by this recall for product correction.
Potentially affected wheelchairs must be inspected for signs of cracking of the top plate assembly. If no cracks are evident, the wheelchair can continue to be used in accordance with the owner's manual until the repairs are completed. If signs of cracking are identified, the wheelchair must not be used until the repairs are completed. If this is the case, Permobil Australia will assist with providing a temporary solution to allow the user to remain mobile during the time between inspection and repair of the affected wheelchair.
If you have any questions or concerns about this issue, speak to the supplier of your Permobil powered wheelchair or call Permobil Australia on 1300 845 483.
Information for health professionals
Please be aware of this issue and advise patients accordingly if they seek advice.
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.