Events

Field Safety Notices about Oxylog 3000, Oxylog 3000 plus

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Drägerwerk AG & Co. KGaA.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    In december 2015, we notified you of an error we noticed in the market for oxylog 3000 family products, where the loss of contact of one of the control buttons triggers an error message (formerly known as a "potentiometer off"). in these cases, acoustic and optical signals are triggered and the respiratory release pressure and ventilation function are interrupted. no injuries were reported in any of these cases. our investigations have shown that fault conditions are triggered by the oxide layer in the potentiometer. oxide layers can form over time when several factors are present, e.G. if you rarely move the buttons or not at all. the proven solution is repeated knob rotation to remove the oxide layer. this recommendation was described in a previous safety notice.

Device

Oxylog 3000, Oxylog 3000 plus

Manufacturer

Drägerwerk AG & Co. KGaA