Aeroneb Solo, Pro, USB and NIVO Nebuliser systems 의 안전성 경고

Safety alert

2014-09-10

2014-09-10

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140910.html

Medical device safety alert: the mains power adapters used in the aeroneb solo, pro, usb and nivo nebuliser systems the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning the mains power adapters manufactured by friwo and used in the aeroneb solo, pro, usb and nivo nebuliser systems . aerogen has received a small number of complaints in relation to the mains power adapter manufactured by friwo gmbh and used in the aeroneb solo, pro, usb and nivo nebuliser systems. the complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use. the reported incidents did not lead to any user injury as the failure was evident and adapter was unusable. additional investigation with the manufacturer friwo has identified that an unknown small quantity of adapters manufactured during the period of week 50/2013 and week 23/2014 could potentially fail in a similar manner whereby the plastic screw pillars can break and the adapter cover can open. friwo have confirmed that they received similar returns from other customers and all of the failures were observed prior to use. however it cannot be ruled out that the adapter may fail during use. if the failure was to occur during use then the internal electrical components of the mains power adapter would become exposed to the user and there is a potential risk of electric shock if the cover falls off during use, with mains power turned on, and the user makes contact with specific recessed components inside the adapter housing. the risk is associated only with the power adapter and not with the aerogen nebuliser systems. the manufacturer advised users to examine the mains power adapter supplied with the aerogen nebuliser system and follow the instructions below: users can continue to use the aerogen nebuliser system until a replacement is received if users inspect the power adapter prior to each use and there is no evidence of damage or separation of the housing and unplug the adapter after each use. do not use the power adapter if there is any evidence that the housing is not intact. if the housing was to fully separate in use, a person may come into contact with live parts and receive an electrical shock. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con449734 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 10 september 2014.