MHRA Issues Medical Device Alert For Ventstar Disposable Breathing Equipment

Specific Products Manufactured By Draeger Are Affected


The Medical and Healthcare Regulatory Agency (MHRA) has issued an alert related to Ventstar disposable breathing systems manufactured by Draeger.

According to the regulator, a manufacturing issue means that there is a risk of inhalation of foreign particles by those using the devices. There is potential that loose adhesive residue could be present inside the breathing system, which may enter the lungs if the affected devices continue to be used by those suffering respiratory problems.

The following products have been affected:

• Packaging box set: 2M86841 with batch numbers 330384.001 - 331661.002 (inclusive)
• Hose packaging: 2M86791 with batch numbers 330384.001 - 331661.002 (inclusive)

The affected devices, which are designed to be used with the Oxylog 2000 emergency transport ventilator, were manufactured between January 2013 and April 2014.

Medical professionals have been asked to identify affected devices, use alternative products from unaffected batches if possible, quarantine the disposable breathing equipment containing the fault and return them to the manufacturer for a replacement.

Expert Opinion
Patients and the families of those with breathing difficulties expect that the devices used to relieve their condition are suitable and safe for use. The fact that foreign particles may be inhaled by those suffering respiratory difficulties is troubling, as these individuals are more vulnerable to these particles and could be being put at further risk of injury.

“Medical device alerts of this nature are concerning and it is vital that the correct steps are taken to prevent patients from suffering as a result of equipment that may cause them to inhale foreign particles.

“The manufacturer needs to investigate how this fault occurred immediately and ensure that its priority is preventing such problems arising with other products in the future.”
Kevin Timms, Solicitor