The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning Breas Vivo 50 Home Care Ventilator [All Vivo 50 Ventilators (215000, 215016) with firmware version 2.04], manufactured by Breas Medical AB.
According to the FDA, unintended treatment termination could result from a keypad malfunction in some situations. The device erroneously interprets this as a Stop Treatment Instruction. An alarm will not sound, or be registered. Accessories and monitoring equipment connected to the Vivo 50 will stop functioning as the device enters stand-by mode.
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-2094-2015&w=07222015&lang=eng
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 24 July 2015