Events

Alerte De Sécurité sur Affinity® Four Birthing Bed

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

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
    2012-05-07
  • Date de publication de l'événement
    2012-05-07
  • 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_20120507.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: hill-rom affinity® four birthing bed medical device manufacturer, hill-rom, has issued a field safety notice concerning affinity® four birthing bed. hill-rom found that some of the affinity® four birthing beds, with serial number h331aa4785 through n081aa7966 produced prior to march 21, 2012, may experience problems with the brakes. the problem may result in unwanted bed movement. the manufacturer has developed an enhanced braking system for these beds and will modify the affected beds. the manufacturer also advised users to test the brake of the beds to make sure that it operates as normal until installation of the new braking system. according to the local supplier, solar-med limited, the affected devices were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 07 may 2012.

Device

Affinity® Four Birthing Bed
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Hill-Rom Affinity® Four Birthing Bed
  • Manufacturer
    Hill-Rom

Manufacturer

Hill-Rom