U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Continuous, ventilator, home use - Product Code NOU
원인
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.
조치
Breas Medical sent Urgent Release: Field Safety Notice letters dated November 7, 2014 and Field Safety Notice dated November 21, 2014
to their customers. The letters identified the affected product, problem and the actions to be taken.
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.
제품 설명
Breas Vivo 50 Home Care Ventilator || Product Usage: || Respiratory Care