The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning NOxBOXi inhaled Nitric Oxide Delivery and Monitoring Device, manufactured by Bedfont Scientific.
A conflict has been identified between the NOxBOXi regulators output and the cylinder status symbols shown on-screen. Due to tolerances on the regulator output, some units may show a cylinder status as empty (red) when in fact they are full and some may show as full (green) when they are empty. With the latter a cylinder could empty without the operators knowledge, the system will switch over to the auxiliary/back-up cylinder, however when that is exhausted and system would then alarm "Supply Critical". If another supply of gas is not available, sudden cessation of the therapy could occur. For patients dependent on this therapy, this failure could result in serious injury or death of the patient.
The manufacturer advises affected users not to use the cylinder status icons on screen to determine gas supply. Furthermore, the manufacturer is evaluating a firmware fix whereby the cylinder status tolerances are widened in order to eradicate the risk of cylinders showing as empty when they are full and full when they are empty. The regulators have a gas pressure gauge built into them which shows the cylinder status and this must be used only until a firmware fix is validated.
For details, please refer to the following link:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON409264
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 07 May 2014