The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom issued a medical device alert concerning Encore, Chorus and Sara Plus standing aids manufactured by ArjoHuntleigh.
ArjoHuntleigh has recently been made aware of an unfortunate serious accident. During exercise, an Encore Standing and raising aid was used to support the patient to stand. The knee pad had been removed. However the support bracket holding the proactive knee pad support had not been removed as described in the instructions for use manual. This results in a vertical square section end of the metal support bracket becoming exposed. It would appear that the patient fell onto the metal bracket causing severe trauma.
The manufacturer supplemented that this accident could have been avoided if the support bracket assembly had been removed with the proactive knee pad support. Therefore, ArjoHuntleigh reminded users that the entire knee and support bracket assembly must be removed when required to do so for exercise. The manufacturer has amended the instructions for use to highlight the need to remove the bracket completely.
According to the local supplier, the affected products have been distributed in Hong Kong.
For details, please refer to the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/MedicalDeviceAlerts/index.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 12 July 2012