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
Continuous ventilator, facility use - Product Code CBK
원인
The expiratory valve in the sv 300 ventilator may stay in the open position if the printed circuit board fails.
조치
An "Urgent: Device Correction" letter dated March 23, 2009 was sent by Federal Express to customers. The letter described the affected product, problem, indications, potential hazard and actions for users. Customers were instructed to complete the "Device Correction -- Customer Fax Response" form and return via fax (732-667-1903) to Maquet Inc. RA/QA. Direct questions to your local Maquet Inc. representative.
Servo Ventilator 300 (Model SV300) and || Servo Ventilator 300 (Model SV300A). || The SV300 is intended for general and critical ventilatory care for use on adults, pediatric, infant and neonatal patients. The unit is designed to be used at the bedside for intra-hospital transport.