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
Condenser, heat and moisture (artificial nose) - Product Code BYD
원인
Connector mount cracks which may lead to a leak failure during use and necessitate immediate replacement in the breathing circuit. if leak exists and is left untreated, patient may be deprived of adequate anesthetic gases over a period of time and serious adverse health consequences may occur.
조치
An Urgent - Field Safety Notice, dated December 4, 2014, was sent to end users that identified the product, problem, and action to be taken. Customers were requested to immediately check inventory, discontinue use and distribution, quarantine. Customers were to return the Acknowledgement form and request a return authorization number from their local Maquet representative for affected devices. A credit will be issued upon receipt of the returned affected product. For questions or for support concerning this issue, a local Maquet representative should be contacted at fieldactions@maquet.com.
MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8. || A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.