Bard Arctic Sun 5000 Temperature Management System 의 리콜

Recall

RC-2015-RN-01116-1

Class II

2015-11-17

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01116-1

Bard medical division (bmd) has identified that the arctic sun 5000 temperature management system with certain serial numbers may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery. the exhausted battery will prevent the arctic sun temperature management system control panel from launching software and initiating operation. this presents a potentially serious issue since the system is used to control patient temperatures within a pre-set range and has the potential of not being available to provide therapy when needed.The issue identified however does not affect an arctic sun 5000 once it is successfully powered up since the batteries are no long being called upon and the unit is operating on mains power.

The sponsor is advising the user that if the device is currently in clinical use, it can continue to be used without concern for this failure. The battery drainage issue only occurs when the unit is off and in stand-by mode. The sponsor will arrange for a technician to come to the user's facility for the evaluation and potential replacement of the affected electronic components. This action has been closed-out on 26/08/2016.