Events

Alerte De Sécurité sur Draeger Infinity Acute Care System in Neonatal Mode

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

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
    2013-11-06
  • Date de publication de l'événement
    2013-11-06
  • 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_20131106.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: draeger infinity acute care system in neonatal mode medical device manufacturer, draeger medical gmbh has issued a medical device safety alert concerning infinity acute care system (iacs) in neonatal mode using software versions vg2.0.3 and higher. it was found in a laboratory test that when a low spo2 (yellow) medium grade alarm was provoked and then paused by the user by using the alarm pause function, the device did not generate the spo2 (red) high grade life threatening spo2 low alarm on the cockpit or central station when the spo2 value was further decreased to reach the set alarm limit for the high grade life threatening spo2 alarm. the correct spo2 value was indicated on all devices and the manufacturer is not aware of any incidents during use on patient. draeger is developing a software upgrade to fix the defect. meanwhile, draeger advises the users not to pause the yellow spo2 low alarm without adequate patient monitoring. according to the local supplier, the affected products were distributed to hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 november 2013.

Device

Draeger Infinity Acute Care System in Neonatal Mode
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Draeger Infinity Acute Care System in Neonatal Mode
  • Manufacturer
    Draeger Medical GmbH

Manufacturer

Draeger Medical GmbH