Events

Alerte De Sécurité sur NOxBOXi Inhaled Nitric Oxide Delivery and Monitoring Device

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Bedfont Scientific.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2015-06-10
  • Date de publication de l'événement
    2015-06-10
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150610.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    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.

Device

NOxBOXi Inhaled Nitric Oxide Delivery and Monitoring Device
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Bedfont Scientific NOxBOXi Inhaled Nitric Oxide Delivery and Monitoring Device
  • Manufacturer
    Bedfont Scientific

Manufacturer

Bedfont Scientific