This German Company Has a Serious Ventilator Problem

First Dräger had a serious U.S. medical device recall related to battery problems on some models. Now there's a new Class I-level recall involving other models with apparently faulty control knobs.

Nancy Crotti

Dräger Medical has recalled three models of emergency transport ventilators because an electrical issue may cause the devices to stop working if the control knobs are not regularly used.

FDA recently announced the Class I recall of 117 Oxylog 2000 plus, 3000, and 3000 plus ventilators sold between April 2007 and December 12, 2015.

No deaths were reported for the latest recall, although one patient had to be resuscitated when an Oxylog 3000 ventilator failed during transport from intensive care to an operating room on October 16, 2015, according to a report filed with FDA.

It is the second Class I-level event for Dräger (Lübeck, Germany) since October, when 2422 PS500 optional battery power supply units for the Evita V500 and Babylog VN500 units were recalled.

In the October recall, FDA said a software issue caused shorter than expected battery run times and also prevented the appropriate alarm from sounding 5 minutes before the battery ran out of power and the device shut down.

Dräger responded: "We recently published voluntary recalls. No patient injury was reported related to the root causes for these recalls. Dräger continues to work diligently towards providing solutions and we will inform customers and authorities about further measures. We are very sorry for any inconvenience this may have caused our customers."

There has been a considerable number of serious recalls related to ventilators, including the Class I recall of the 248 Hamilton Medical AG ventilators, circuit board glitches related to a Covidien device, and nonfunctioning buttons on a GE ventilator. 

Inappropriate patient ventilation can cause lung injury in intensive care patients, proving fatal in some cases, according to ECRI Institute. While ventilators include modes and features designed to address this problem, ventilator-induced lung injury (VILI) continues to be a problem. One contributing factor is that complex ventilator functionality included in some devices can be difficult for some clinicians to understand. In addition, there is a lack of standards among manufacturers regarding ventilator terminology, which can exacerbate confusion among clinical staff.

Basically, when things go wrong with ventilators, they can really go wrong, with serious and even deadly consequences. The same goes for another type of medical device that seems prone to many serious recalls: infusion pumps. 

Nancy Crotti is a contributor to Qmed and MPMN.

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