Dive Brief:
- The U.S. Food and Drug Administration has categorized Draeger Medical’s recall of 300 transport ventilators as a Class I event.
- The Luebeck, Germany-based company contacted customers last month after receiving reports that Oxylog 3000 Plus Emergency and Transport Ventilators stopped providing ventilation because of depleted batteries, even after being reconnected to power.
- The news comes two months after the FDA categorized Draeger’s recall of other ventilation equipment as a Class I event. Draeger face masks were the subject of a Class I recall earlier this year too. Because the devices are used in severely ill patients, problems can cause serious injuries.
Dive Insight:
Demand for Draeger’s ventilators surged during the COVID-19 pandemic, and the company is currently working to address a high backlog due to an increase in orders from China that drove an 18% rise in first-quarter net sales year over year.
The company’s Oxylog devices allow healthcare providers to transport people who need full or partial breathing assistance from a mechanical ventilator. When moving patients in an ambulance or aircraft, or through the hospital and recovery room, staff can hook patients up to the devices to keep them ventilated until they reach their destination.
Draeger has received six complaints related to the transition from battery to AC operation. None of the complaints describe injuries or deaths, but the FDA sees the potential for the problem to cause serious harm such as respiratory distress and slow heartbeat, leading it to identify the notice as a Class I event.
The issue affects 300 ventilators distributed in the U.S. between 2012 and 2022. Draeger is asking users of the devices to take certain precautions to ensure the machines continue to provide ventilation. Every time a ventilator displays the “No int. battery charging” alarm message, the user should remove and reinsert or replace the battery while keeping the device connected to the main power supply.
Draeger is also asking users to disconnect and reconnect devices to an AC main power supply before switching to the battery. The process enables users to check that the indicator lights show the battery is working properly.