Important Safety Alerts

The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom (UK) posted a medical device safety alert concerning the following SenSit chair manufactured by Protac A/S:

• Product no.: 600-601 standard model
• Product no.: 600-701 high model
• Product no.: 600-601-3500 standard model
• Product no.: 600-701-3500 high model

Protac has heard that an over-excited child in the UK managed to get his head caught in one of the carrying straps on the Protac SenSit chair. As the strap sat around the child's throat, he was unable to free himself. However, the staff managed to cut the handle so that fortunately nothing happened to the child.

To minimize events of this type from recurring, the manufacturer has implemented the following measures:

• Protac is sending a safety notice together with a warning (Please note! Take care to ensure the user's head does not get caught in the carry straps.) to institutions and private customers who have purchased or who are using Protac SenSit chairs to draw their attention to this potential risk.
• Protac is also sending the safety notice with the warning to all foreign dealers in Europe and Australia, who must in turn inform their customers, institutions and private customers of this potential risk.
• Protac has redesigned the carrying straps on its Protac SenSit chair so that the new chair has new and safe straps.
• Protac advises the customers to assess the safety risk and implement any precautionary measures whenever necessary.

For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON286973

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

Posted on 2 July 2013