The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom has posted a medical device safety alert concerning R40PED Powerchair manufactured by Pride Mobility Products Corporation. All the R40PED with MBL, LL-1000 power seat tilt actuator; manufactured from 26 April 2012 to 20 May 2013 are affected.
The manufacturer has found that there is a potential for the stop bushing on the seating tilt actuator to fail. This may lead to a separation of the actuator's internal components and the seat tilting backwards to a degree much greater than intended. Furthermore, the end user may not have any means of detection for this failure mode prior to such an event. The manufacturer has received 2 consumer complaints on this issue. There is a potential that such a malfunction in the product can occur and could lead to serious personal injury and/or death.
In order to alleviate any potential for this type of malfunction, the manufacturer will replace the affected actuator with a new assembly that has a more robust and proven stop bushing.
For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON306142
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 August 2013