FDA doles out Class I recalls to 2 breathing support devices from Dräger, NOxBOX

FDA doles out Class I recalls to 2 breathing support devices from Dräger, NOxBOX

A pair of recalls of devices made by Germany’s Dräger Medical and U.K.-based NOxBOX have each been given the FDA’s most serious Class I rating, the agency announced in separate notices this week.

Both of the devices are used to provide respiratory support, and in both cases, the devicemakers and FDA have advised healthcare providers that they can still be safely used as long as certain precautions are taken.

Dräger’s is the smaller of the two recalls. It concerns its Oxylog 3000 Plus Emergency and Transport Ventilator, which is used, as the name suggests, to provide mechanical breathing assistance while a patient is being transported via ambulance or aircraft, or simply between rooms of a hospital.

The recall spans just 300 machines that were distributed throughout the decade spanning April 2012 and June of last year.

According to the FDA’s notice, Dräger began the recall last month after discovering that the ventilators may not automatically switch from battery to AC power after being plugged in, even if the battery has run out. In those cases, once the battery has been depleted, even if a ventilator is plugged in, it may simply shut off and stop providing breathing support, regardless of whether it’s plugged into an outlet.

Without the needed support, patients may experience difficulty breathing, a lack of oxygen or a slowing or stopping heartbeat, among other severe and potentially fatal effects. To date, per the notice, Dräger has received six complaints related to the issue, with no reports of injury or death.

Because the issue will be accompanied by a battery alarm, Dräger has advised healthcare providers using the ventilator to immediately remove and either reinsert or replace the battery if the alarm sounds. They should also disconnect and reconnect to AC power before switching to battery power to ensure the power mode has been properly changed; a proper switchover will be accompanied by green indicator lights on the ventilator, rather than red ones.

In the meantime, Dräger informed users of the affected machines that its service representatives would be contacting them to coordinate a circuit board firmware update.

The NOxBOX recall, meanwhile, covers more than 750 devices that were sold between May 2021 and February of this year. At issue is the company’s flagship NOxBOXi system, which delivers inhaled nitric oxide gas therapy through a ventilator to help newborns in respiratory distress breathe normally, including those with congenital heart disease.

As described in the Class I recall notice, some NOxBOXi systems have been found to have a misaligned check valve within the internal manifold, potentially causing the manifold to fail. If that happens, it may cause nitric oxide or oxygen to leak out of the device and could either prompt an earlier-than-expected change of gas cylinders or stop a needed cylinder change from occurring at all.

If that failure occurs and creates an interruption in a patient’s nitric oxide therapy, it could result in reduced oxygen saturation levels or increased pressure in the pulmonary artery—both of which can be especially dangerous for babies with congenital heart disease, per the FDA.

So far, NOxBOX hasn’t reported any complaints linked to the recall. It has advised healthcare providers to continue using affected NOxBOXi systems as long as they pass a high-pressure leak test when activated and don’t sound any alarms. Even so, while using an affected device, clinicians should have a backup device and backup gas cylinders at the ready and always pay attention to the results of the start-up leak test and any alarms.

NOxBOX is in the process of obtaining new manifolds, per the notice, and ultimately plans to correct or replace all affected devices on a rolling basis.

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