Medical device manufacturer, Draeger Medical GmbH, has issued a medical device safety alert concerning its Oxylog 3000 and Oxylog 3000plus.
In December 2015 the manufacturer informed customers about an error condition observed in the market with products of the Oxylog 3000 family, where the loss of contact of one of the control knobs generates an error message (previously referred to as "Poti unplugged"). In these cases, acoustical and visual alarms are triggered, the breathing system releases pressure and the ventilation function stops operating. Personal injury was not reported in any of these situations.
The manufacturer's investigations indicate that the error condition is caused by an oxide layer in the potentiometer. These oxide layers may accumulate over a longer period of time if various factor collude i.e. if the knobs are moved rarely or never. A verified remedy is repeated twisting of the knobs that removes the oxide layer.
However, this particular error condition was still reported from the field after the safety notice. The remedy of twisting the knob is still considered effective. Nonetheless, to reduce the impact of this special error condition the manufacturer has developed a new software that reduces the impact of the error condition.
Software version 1.06 will now be introduced for Oxylog 3000pIus, version 1.23 for Oxylog 3000, respectively. The manufacturer will contact customers to schedule a time to perform the software update.
According to the manufacturer, whenever a "Control knob faulty" condition will occur with a device being equipped with the new software the device will continue to ventilate with the last valid settings, display for example the values for tidal volume in case of a defective potentiometer for VT and post the corresponding alarm. As reflected in the amended instruction for users, the customers are advised to check patient's condition and the ventilation.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 12 December 2016