Advice
Regulatory information
Regulatory information
The console of the Arctic Sun system was CE marked as a class IIb device, and the gel pads as a class I device, in May 2004. Bard distributes the device in the UK.
A search of the Medicines and Healthcare products Regulatory Agency website revealed 2 field safety notices for this technology.
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FA2015-30: premature drainage of the internal control panel coin cell battery responsible for maintaining the system clock and static RAM. This could render the device unresponsive upon system start-up. Bard inspected all units shipped from April 2011 to February 2015 to determine if they were affected by this issue, and affected parts were replaced by a Bard technician. The company has confirmed that this issue has now been resolved.
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FA2016-47: Bard completed an internal health hazard evaluation and concluded that there is a highly remote probability of risk of harm to a patient or user being exposed to nontuberculous mycobacterium through the Arctic Sun system based on use of the device under existing labelling. A field safety notice was handed to all personnel using the device.