Events

Alerte De Sécurité sur Centuris P750 Beds

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
    2017-03-23
  • Date de publication de l'événement
    2017-03-23
  • 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_20170323.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 centuris p750 beds medical device manufacturer, hill-rom, has issued a medical device safety alert concerning its centuris p750 beds [model number: p75051x, p75052x, p75061x, p75062x, p75071x, p75072x, p75081x, p75082x, p750askd and p750a000001; serial number: from o348cc0046 to r365cc6446]. the manufacturer has received reports of the centuris p750 bed side rail lockout indicators flashing/ blinking and the bed controls getting locked. the bed reset controls may help to resolve the issue in certain circumstances but not always. after an extensive review of this issue, the manufacturer has determined that the majority of these lockouts are related to a technical problem on multiple printed circuit boards (pcbs) within each centuris bed. based on a thorough health hazard evaluation and availability of a manual release for cpr, the manufacturer has determined that the centuris beds are safe. while awaiting correction, affected users may continue to use the device and maintain awareness of the bed reset controls. according to the local supplier, the affected products are distributed in hong kong if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 march 2017.

Device

Centuris P750 Beds
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Hill-Rom Centuris P750 Beds
  • Manufacturer
    Hill-Rom

Manufacturer

Hill-Rom