Events

Alerte De Sécurité sur Dynamis and Gerialit Beds with DEWERT electrical system

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
    2013-01-29
  • Date de publication de l'événement
    2013-01-29
  • 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_20130129.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 dynamis and gerialit beds with dewert electrical system the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning dynamis and gerialit beds manufactured between october 1995 and june 2001 with dewert electrical system, manufactured by hill-rom. the affected model numbers are li146b1—li146bi, li146d1—li146di, li147b1—li147d1, li150a0—li150b0, li163b1—li163c1, prs0128, prs0199, prs0201, prs2001. the manufacturer wants to make aware of a potential safety issue regarding dynamis and gerialit beds manufactured and shipped from october 1995 to june 2001 that have dewert control boxes. it is possible for there to be unintentional movement of the bed when it is plugged in, including sudden collapse to the lowest position. in an effort to mitigate the potential for injury, the manufacturer requested customers that the labels should be applied to both sides of the bed as a reminder where a hand should not be placed, and to not climb under the bed. the manufacturer also advised customers to make sure that staff, patients, caregivers, and visitors do not work or crawl under any bed or other areas where unintended quick return to lowest position or collapse of the bed could cause entrapment that serious injury of death could occur. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con226926 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 29 january 2013.

Device

Dynamis and Gerialit Beds with DEWERT electrical system
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Hill-Rom Dynamis and Gerialit Beds with DEWERT electrical system
  • Manufacturer
    Hill-Rom

Manufacturer

Hill-Rom