The Medicines and Healthcare Regulatory Agency (MHRA), United Kingdom has posted a field safety notice concerning MEDUMAT Transport ventilator (with and without CO2 measurement) manufactured by Weinmann Emergency Medical Technology GmbH & Co. KG. All the serial numbers are affected.

According to the manufacturer, in some cases MEDUMAT Transport ventilators have failed as a result of a device-internal fault. There is the potential risk of this fault recurring sporadically in future too.

Furthermore, according to the manufacturer, in the interaction of the internal structural components and sensors for internal device monitoring, device internal occurrences of this kind may coincide unfavourably, resulting in an undefined operating state and the device displaying a "device malfunction" for safety reasons.

The manufacturer has developed new device software version 2.35. Moreover, affected users are advised to take the following necessary actions:

• All MEDUMAT Transport devices must be verifiably updated with the new XC firmware version 2.35 and embedded PC Version 2.35.
• Affected users can continue to use their MEDUMAT Transport devices until the update has been installed. Users are reminded to observe the recommendations and the addition to the Instructions for Use as mentioned in this field safety notice.

For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON323827

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

Posted on 22 October 2013