Events

Alerte De Sécurité sur VersaCare 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
    2012-08-29
  • Date de publication de l'événement
    2012-08-29
  • 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_20120829b.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 versacare bed medical device manufacturer, hill-rom, has issued a medical device safety alert concerning versacare bed (revision e through j, serial number h345ad5880 through n138al9061). according to the manufacturer, hill-rom versacare bed has a built-in safety feature intended to protect the patient under certain conditions where bed movement could cause harm. this functional lockout feature is designed to disable the bed. however, the manufacturer has received complaints that the lockout is occurring on the bed of the captioned model when it should not. after an extensive review of this issue, the manufacturer has determined that the majority of these lockouts are related to technical problem on the printed circuit (pc) board within each versacare bed siderail. the manufacturer has identified the root cause to an intermittent connection between a chip and socket on the pc board. the manufacturer will provide a correction for the chip/socket problem which involves replacement of the pc boards in both head-end siderails. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 29 august 2012.

Device

VersaCare Bed
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Hill-Rom VersaCare Bed
  • Manufacturer
    Hill-Rom

Manufacturer

Hill-Rom