Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
데이터 추가 비고
원인
There have been reports of failures of cap / diaphragm assemblies. specific lots of cap/ diaphragm assemblies used with 3100a or 3100b high frequency oscillatory ventillators could fail thereby preventing the targeted mean airway pressure (39 - 43 cm h20) being reached during system calibration test set up prior to being used on patients.
Model Catalog: 3100B (Lot serial: >10 lot numbers.); Model Catalog: 3100B (Lot serial: Contact manufacturer.); Model Catalog: MODEL 3100A (Lot serial: Contact manufacturer.); Model Catalog: MODEL 3100A (Lot serial: >10 lot numbers.)
제품 설명
High Frequency Oscillatory Ventilator Model 3100B (Cap Diaphragm)