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 - Product Code CBK
원인
Some servo ventilators 300/300a and servo ventilator 900c/d/e should not be used with a system that may generate negative pressure below -100 cm h2o (closed system suctioning) due to the risk of damaging the ventilator's pressure transducers.
조치
Maquet sent Device Correction letters commencing 11/17/09 and ending 11/23/09 by Federal Express.
Serial Numbers 010001-188499 Ventilators within the specified serial number range, that are marked with one of the following labels on the inside of the lid of the pneumatic unit are exempted since they have already been fitted with a new type of the pressure transducer. 1. Upgrade EMO 12/02/1; 2. Upgrade SV300 6682-745 SV900 66 82 747.