Oxylog 3000 Plus (ventilator)

2023: Recall of defective equipment

On July 13, 2023, the U.S. Food and Drug Administration announced that Draeger Medical was recalling defective ventilators of the Oxylog 3000 Plus family.

These devices can be used in ambulances and on board aircraft. They focus on patients who require full or partial breathing assistance. The reason for the recall is the risk of unexpected battery discharge and subsequent shutdown of the ventilator. In some cases, this can cause significant harm to people's health and even provoke a death.

Stopping ventilation can cause difficulty breathing (respiratory distress), lack of oxygen (hypoxia), slow heart rate (bradycardia), sudden cardiac arrest (cardiopulmonary arrest), other severe injuries or death, the notice released says.

Hundreds of devices numbered 5704811 and 5704813 fall under the recall program. Draeger supplied these defective ventilators from April 30, 2012 to June 13, 2022. At least six cases of sudden discharge of batteries are reported (as of mid-July 2023). Deaths due to the problem were not recorded by the specified date.

According to the FDA, Draeger sent an urgent recall letter to affected customers. The manufacturer recommended that medical institutions ensure that the battery is always removed and/or replaced with a new one after receiving a fault alarm. This will help avoid negative consequences for patients and minimize the risks of impaired breathing. Users must also ensure proper switching by disconnecting and reconnecting the device to an AC source before using battery power.^[1]

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