Dräger Recalls Faulty Ventilators
About the Dräger Ventilator Recall
The ventilators are medical devices which provide breathing support to adults and children (including premature babies) during hospitalization and patient transport.
According to the FDA, the battery that powers the affected ventilators does not last as long as expected and the power indicator on the device gives false readings regarding how much battery life is remaining on the product.
Description of Recalled Ventilators
- The recall affects the Envita 500 and the Babylog VN500 medical ventilators produced by Dräger Medical.
- Ventilators were sold under catalog numbers 8416400 and 8417400.
- The affected devices were manufactured and distributed from June 1, 2011 to June 30, 2015.
When the low power alarms sound on the devices, the battery indicators do not give accurate information as to how much battery life the ventilator has before it will shut down. If the device were to shut down it could result in the patient not receiving sufficient oxygen, which could cause injury or death.
The FDA has classified this as a ‘Class I’ product recall. A Class I recall is “the most serious type of recall” and “involve(s) situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death”.
Medical professionals should notify all device users of this issue. Instructions on how to handle affected devices can be found on the FDA Recall Notice concerning this product.
Consumers with questions can contact Dräger Medical Customer Support at 800-543-5047. At the prompt, press 1, then 2, then 32349.
Health care professionals and consumers may report any incidents or issues experienced with this device to MedWatch: The FDA Safety Information and Adverse Event Reporting Program online.