Events

Alerte De Sécurité sur Contoura 450 and Project Versions of 25000E/L Hospital Bed Frames

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

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
    2013-11-26
  • Date de publication de l'événement
    2013-11-26
  • 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_20131126.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: arjohuntleigh contoura 450 and project versions of 25000e/l hospital bed frames the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a medical device safety alert concerning contoura 450 and project versions of 25000e/l hospital bed frames manufactured by arjohuntleigh. model numbers c450l, 25000e/lpd73, 25000e/lpd77, 25000e/lpd75, 25000e/lpd76, 25000e/lpd90 and 25000e/lpe12 are affected. spare backrest actuators (part number s6686, linak ref. 321021) for the bed frames indicated above are supplied with a pre-wired safety limit switch (sls) that operates as the actuator extends and prevents the backrest being driven to angles greater than 60o above the horizontal. according to the manufacturer, approximately 200 of these actuators sold as spare parts were supplied with the sls incorrectly connected. on beds fitted with these parts, if the backrest is driven to an angle of 60o, the sls does not operate as intended and the backrest continues to rise until the actuator reaches its limit of travel. once in this position, it may not be possible to lower the backrest, either electrically or by using the manual cardiopulmonary resuscitation (cpr) release. it is potentially life-threatening if the backrest cannot be lowered when a patient requires cpr or other emergency treatment. arjohuntleigh advises the users to test all suspect actuators according to the instructions given in the field safety notice. faulty actuators should be returned to arjohuntleigh for modification or disposal. according to the local supplier, the affected products were not distributed in hong kong. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con336744 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 26 november 2013.

Device

Contoura 450 and Project Versions of 25000E/L Hospital Bed Frames
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: ArjoHuntleigh Contoura 450 and Project Versions of 25000E/L Hospital Bed Frames
  • Manufacturer
    ArjoHuntleigh

Manufacturer

ArjoHuntleigh