Events

Alerte De Sécurité sur Capnostream 20 and Capnostream 20p Bedside Patient Monitors

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

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
    2018-08-06
  • Date de publication de l'événement
    2018-08-06
  • 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_20180806.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: medtronic capnostream 20 and capnostream 20p bedside patient monitors medical device manufacturer, medtronic, has issued a medical device safety alert concerning its capnostream 20 and capnostream 20p bedside patient monitors. the manufacturer has received customer reports that the date/time, nurse call and alarm settings of capnostream 20 and capnostream 20p bedside patient monitors may reset to the factory default settings when the monitor is powered off. there have been no reports of patient injury related to this issue. investigation revealed that the cause for the reset to the factory default settings is the accelerated discharge of the internal coin cell battery. user-defined institutional default settings are not lost if the monitor is not powered off, even when the internal coin cell battery is depleted. this issue does not affect the operation of the monitor’s removable li-ion battery or any other aspect of the monitor’s operation. only the reset of user-defined institutional default settings as described are affected. the manufacturer is developing a software update that will ensure user-defined institutional default settings are not lost if the monitor is powered off, except the date/time, regardless of the internal coin cell battery charge level. this software update will be available in october 2018. affected user should download the software update from the manufacturer’s website when it is available. the manufacturer will issue an update to the operator’s manual to note that the date/time setting should be verified at power on. the manufacturer is recommending continued use of capnostream devices. users should confirm that the date/time is accurately displayed. if the date/time requires reset, all user defined settings, such as alarms and nurse call, will also require reset until the software is updated. affected users should follow the instruction in the operator’s manual to set user-defined default settings. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 6 august 2018.

Device

Capnostream 20 and Capnostream 20p Bedside Patient Monitors
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Medtronic Capnostream 20 and Capnostream 20p Bedside Patient Monitors
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH