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 - Product Code CBK
원인
Gas input pressures over 62 psi may cause cpap pressure oscillation.
조치
The recalling firm issued a recall letter to their customers dated 9/19/05 informing them of the problem and the corrective action. (fitting unit with external 50 psi pressure regulator for both air and oxygen)
World wide (including medical facilities in AZ, CA, CO, GA, IA, IL, MA, MD, MN, MO, NC, NE, NH, NJ, OH, OK, OR, PA, PR, TN, TX, VA, WI, and WV. Japan, Ireland, Great Britain, Sweden, Portugal, France, Chile, Argentina, Hong Kong, South Africa, Greece, Egypt, Saudia Arabia, Norway, Spain, Belgium and Canada
제품 설명
NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous). Model number 1025310