The United States Food and Drug Administration (FDA) has issued an alert concerning Flow-i Anaesthesia System, manufactured by Maquet Cardiovascular. [Model numbers: C20 (for United States), C30 and C40; Part numbers: 66 77 200 (United States only), 66 77 300 and 66 77 400; Serial numbers: 2743, 2852, 2854, 2855, 2856, 2858]
According to the manufacturer, the system is intended for use on neonatal to adult patient populations in hospital environments, except MRI environment by healthcare professionals trained in inhalation anesthesia administration.
Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit boards (PCBs) that control the sub-systems. The problems manifested as multiple re-starts of the sub-systems and, in a few instances, disabling of the system has occurred. Replacement PCBs are now available to correct the issues.
For details, please refer to the FDA website:
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0804-2016&w=03022016&lang=eng
Posted on 7 March 2016