The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom has posted a medical device safety alert concerning NOxBOXi Inhaled Nitric Oxide Delivery and Monitoring Device , manufactured by Bedfont Scientific Ltd. The affected serial numbers are identified as follows:
According to the manufacturer, a fault has been identified within the NOxBOXi firmware, whereby after 6 days of continuous use the screen may freeze/lock and will not respond. After another unknown period of hours this may cause the system to crash and enter "safe" mode, at this point delivery of nitric oxide (NO) therapy is stopped.
If the patient is dependent on inhaled nitric oxide, this failure could result in serious injury or death of the patient.
The manufacturer advises users not to use the NOxBOXi continuously for a period longer than 6 days until a firmware upgrade is implemented on the device.
A firmware fix has been released to prevent this fault from occurring (0.0.12.1), which users must install on their device immediately. If the device already has this firmware version installed no action is required.
For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON341279
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 11 December 2013