Important Safety Alerts

The Medicines and Healthcare Products Regulatory Agency (MHRA) of United Kingdom has posted a medical device safety alert concerning Inspiration LS, and i Series ventilator systems manufactured by eVent Medical. All Inspiration ventilators i Series and LS 12.1" LCD built before 21 January 2015 are affected.

According to the manufacturer, a component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming. This failure could result in death or serious injury to a patient.

The manufacturer advises users to discontinue use of the affected ventilators immediately until correction is completed.

The manufacturer also advises affected users to take the following actions:-

• For users who have the LS, 5i, or 7i Inspiration Ventilator System models subject to this Field Safety Notice, the manufacturer has identified a correction to this issue which requires removal of the potentially faulty component from the power board.
• For users who have older models that are not the LS, 5i, or 7i model, these ventilators should be taken out of service. These models are no longer supported with spare parts or software versions and should be retired.

For details, please refer to the MHRA website:
https://mhra.filecamp.com/public/file/2bog-sl9dth3p

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 20 October 2015