Events

Alerte De Sécurité sur Ceiling Supply Units [CSU 603X/ 803X]

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
    2013-08-09
  • Date de publication de l'événement
    2013-08-09
  • 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_20130809.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 ceiling supply units [csu 603x/ 803x] medical device manufacturer, draeger medical gmbh, has issued a medical device safety alert concerning ceiling supply units (csu) [model: csu 603x/ 803x] with year of construction between 1997 and 2003. in the course of the manufacturer’s international market observations, there were cases in which the drive screw in the motor unit, which lifts and lowers the lower lift arm, broke. as a result, the lift arm fell down approx. 60 cm (23.6 inches). if the drive screw breaks, personnel standing under the csu may be injured or objects damaged. an inclined alignment of the motor unit has been identified the root cause for the drive screw breaking. in the cases in question, this inclined alignment was caused by: blocked joint axes or insufficient symmetry of the support plate (incorrect/inclined alignment of the lift arm) or previous mechanical damage due to excessive dynamic load (collision of the arms, clamping the arms into window lintels etc.). this can result in a deformation of the carrier plate and thus cause a fatigue fracture of the drive screw. these three potential causes can be detected during maintenance. additionally, the performance of regular maintenance can prevent this type of failure. according to the information in the instructions for use, ceiling supply units must be maintained in regular intervals. this is the only way to ensure safety and reliability during the period of use. the manufacturer advises a further inspection of the location of the motor unit according to the test instructions they given together with the field safety notice if users had no service contract with the company. if users identify an inclined alignment of the motor unit, they should replace it as soon as possible. in such a case, special care should be taken that no persons or objects are under the media head until the motor unit has been replaced. 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 9 august 2013.

Device

Ceiling Supply Units [CSU 603X/ 803X]
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Draeger Ceiling Supply Units [CSU 603X/ 803X]
  • Manufacturer
    Draeger Medical GmbH

Manufacturer

Draeger Medical GmbH