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
Ventilator, Continuous, Facility Use - Product Code CBK
원인
Failures of the air and oxygen gas modules occurred because of misuse/non-compliance of directions.
조치
Customer letter mailed on January 3, 2005 via certified postage, with return self-addressed postcards that customers must complete to acknowledge receipt of the instructions to refer to their Service and Operating Manuals.
The ventilators were distributed to hospitals nationwide. There are 33 VA Medical Center and DOD hospitals nationwide.
제품 설명
Servo-Ventilator, SV300/300A, Part numbers 6070391 and 6424704. The Safety Alert action targets customers with Unit Serial numbers 24578 and lower. Manuf. Maquet Critial Care AB, SE-171 95 Solna, Sweden.