Events

Alerte De Sécurité sur Monitor Arm AC 3000

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

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
    2013-11-29
  • Date de publication de l'événement
    2013-11-29
  • 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_20131129.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: draeger monitor arm ac 3000 medical device manufacturer, draeger medical gmbh, has issued a medical device safety alert concerning its adjustable monitor arm [model no.: ac3000; part no.: g92756 and g94499]. according to the manufacturer, the other part numbers are not affected. the manufacturer has discovered a case in which the monitor support bracket detached from the joint pin at the bottom of the height adjustable spring arm ac3000. the monitor support bracket fell down together with the monitor until it was only held by electrical cable connections. although no one was injured, a falling monitor support has the potential to cause personal injury. an inspection of a further seven monitor brackets in the same hospital identified severe wear on the ring groove responsible for the joint pin. the manufacturer advises affected users to handle the monitor arm with care and to pay attention to any increasing free play between the pins and the monitor arm. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 29 november 2013.

Device

Monitor Arm AC 3000
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Draeger Monitor Arm AC 3000
  • Manufacturer
    Draeger Medical GmbH

Manufacturer

Draeger Medical GmbH