The US Food and Drug Administration has issued a Class I recall of Draeger Medical’s Oxylog 3000 Plus Emergency and Transport Ventilator, saying that it “may cause serious injury or death”.
Draeger Medical initiated the recall on 12 June after receiving six complaints about the device stopping ventilation due to power rerouting issues. After the battery becomes depleted, the system should switch to AC power once plugged in. However, there were incidences of this not happening and the system continued using the battery until it was fully drained.
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There have so far been no injuries and no death due to the device, but the FDA issued the recall as Class I due to the dangers of unexpected ventilation cessation. As per an FDA alert, patients could be exposed to respiratory distress, hypoxia, bradycardia, or cardiac arrest. The company added that a battery alarm does occur with this issue.
German respiratory technology company Draeger Medical has recalled 300 devices distributed over a ten-year period from April 2012 to June 2022. In a letter to customers of the device, the company issued steps that need to be taken to ensure the device correctly uses an AC main power supply.
The recall compounds a difficult year for Draegar after it recalled more than half a million infant breathing circuit/anaesthesia kits due to a manufacturing error.
In a separate development in the ventilator device space, the FDA also recalled NOxBox’s NOxBOXi nitric oxide delivery system due to gas leakage issues.
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By GlobalData
