NOxBOXi Inhaled Nitric Oxide Delivery and Monitoring Device 의 안전성 경고

Safety alert

2015-06-10

2015-06-10

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20150610.html

Medical device safety alert: bedfont scientific noxboxi inhaled nitric oxide delivery and monitoring device medical device manufacturer, bedfont scientific, has issued a medical device safety alert concerning its noxboxi inhaled nitric oxide delivery and monitoring device [model number: noxboxi; serial numbers: ni100233, ni10036; software version 16.2, 15.3]. issue 1: ‘critical delivery fault’ alarm the noxboxi firmware monitors the flow of gas through the device in order to ensure it doses the correct values to the patient. if this flow breaches the acceptable tolerance in the event of a component failure a ‘critical delivery fault’ alarm will sound and dosing to the patient will cease. this acceptable tolerance is measured in units of voltage (v). it has been identified that the acceptable tolerance in the firmware may be too close to the tolerance of the mass flow sensor used to monitor the gas flow. therefore it is possible that when changing doses in large increments or if the device is connected to a high frequency ventilator set to a frequency of 10hz and the mass flow sensor is at the upper or lower end of its technical tolerance, the ‘critical delivery fault’ alarm can be falsely triggered by a momentary spike in voltage. this alarm needs to be resolved manually. issue 2: anomaly leading to device shut down during use there is a small possibility that due to an operating system framework anomaly, the device may shut down during use, the user will be alerted by the visual led alarm band flashing. the manufacturer is evaluating a firmware fix to eradicate the above two issues. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 10 june 2015.