FDAnews
www.fdanews.com/articles/176072-dr%C3%A4ger-pulls-117-emergency-transport-ventilators

Dräger Pulls 117 Emergency Transport Ventilators

April 8, 2016

Dräger is recalling 117 emergency transport ventilators due to a system error that may lead to a halt in ventilation therapy.

The recall — designated by the FDA as Class 1 — involves the Oxylog 2000 plus, Oxylog 3000 and Oxylog 3000 Plus ventilators. They were distributed from April 1, 2007 to Dec. 12, 2015.

An electrical issue may cause the device to stop working if the control knobs are not regularly used, according to an FDA notice. If the device operator does not intervene, then the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death.

“As part of our product monitoring, we have become aware of situations where the error message ‘Poti unplugged’ was generated. In these cases, an acoustic and visual alarm is generated, the breathing system releases pressure, and the ventilation function stops operating,” says company spokeswoman Marion Varec.

No injury was reported in any of these situations, said Varec.

Dräger sent a letter to customers on Dec. 21, 2015, with instructions on how to resolve the issue.

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