The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a medical device safety alert concerning the power adapter manufactured by FRIWO used in PARI SOLE N Inhalation Device.
PARI GmbH has received a small number of complaints regarding the mains adapter manufactured by FRIWO that is used with the PARI SOLE N inhalation device. The complaints received concerned the mains adapter overheating and causing a certain part of the power adapter housing to melt. It may pose the risk of electric shock or fire.
None of the reported incidents led to any personal injury or damage due to fire.
The manufacturer advised users to inspect the power adapter before each use to ensure that it is not damaged. The device must not be switched on if damaged or damage is suspected. Users should contact the manufacturer for replacement of the power adapter.
For details, please refer to the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON184398
If you are in possession of the product, please contact your supplier for necessary actions.
Posted on 11 September 2012