Device product
Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care
Z-2094-2015
Product summary
- Firm
- Breas Medical AB
- Event
- Event 69760
- Status
- Terminated
- Classification
- Class II
- Quantity
- 846 US
- Official record key
device-enforcement:Z-2094-2015
Official wording
Reason: 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.
Code information: All Vivo 50 Ventilators (215000, 215016) with firmware version 2.04
Distribution pattern: Worldwide - United States Nationwide Distribution and the countries: Argentina, Belgium, Chile, Cyprus, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Netherlands, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Thailand, Turkey, UAE and United Kingdom.
Derived failure modes
-
Unknown
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.