Events

Alerte De Sécurité sur Dual Hemo MCable pod used with the Infinity Acute Care System (IACS) Monitoring Solution

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

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
    2017-10-03
  • Date de publication de l'événement
    2017-10-03
  • 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_20171003.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
    Field safety notice: dräger dual hemo mcable pod used with the infinity acute care system (iacs) monitoring solution medical device manufacturer, dräger medical systems, inc., has issued a safety alert concerning its dual hemo mcable pod used with the infinity acute care system (iacs) monitoring solution. the manufacturer has determined through internal testing that dual hemo mcable pods with revision index (ri) 15 and 16, which are used with the dräger infinity acute care system, may permit liquid ingress inconsistent with their ipx4 rating, which could potentially result in an incorrect measured value of invasive blood pressure. the manufacturer has not received any complaints and is not aware of any negative patient consequences arising from this issue. revisions prior to ri 15, with proper orientation will still maintain its designated ipx1 rating and are not within the scope of this safety notice. in addition, revisions labelled ri 17 and greater are not affected by this notice because these revisions continue to meet the ipx4 standard. affected users are requested to take the following actions: contact the manufacturer to receive a sleeve that can be applied to protect against liquid ingress see the safety notice provided by the manufacturer for required upright orientation of the dual hemo mcable pod and installation instructions for the sleeve. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 3 october 2017.

Device

Dual Hemo MCable pod used with the Infinity Acute Care System (IACS) Monitoring Solution
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Dräger Dual Hemo MCable pod used with the Infinity Acute Care System (IACS) Monitoring Solution
  • Manufacturer
    Dräger Medical Systems

Manufacturer

Dräger Medical Systems