Safety Alert Or Field Safety Notices for Oxylog 3000 and Oxylog 3000 plus ventilator

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.

This error condition (referred to by Dräger as ‘Poti unplugged’) which could result in the ventilator stopping, is caused by an accumulation of an oxide layer in the potentiometer when these are rarely (or never) moved. The layer develops over time, but twisting the potentiometer knobs prevents this, as described in Dräger’s FSN that was sent to customers in 2015.Dräger have now issued software which enables the ventilation to continue with the last, valid parameters (and posts the corresponding alarms). Additionally, the new software prompts turning of the potentiometer knobs in the pre-use device check, so the issue should not occur.