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
Gas-Machine, Anesthesia - Product Code BSZ
원인
The anestar and anestar plus anesthesia system may produce periods of high positive end-expiratory pressure (peep), in both manual and mechanical ventilation mode due to an issue with the applied pressure limit (apl) valve.
조치
Field correction communications were sent 3/17/2006 to all accounts via certified mail, return receipt requested, signature required.
The units have been distributed to distributors and end-users such as hospitals and clinics nationwide. There are 3 foreign accounts in Australia, El Salvador, and Venezuela.