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
Ventricular (Assist) Bypass - Product Code DSQ
원인
Bi-ventricular support system may switch to battery when primary voltage (ac) is available.
조치
Abiomed notified customers by letter on 8/19/03 advising users of the problem and requesting that the unit not be used until a field service representative corrected the device.