Events

Alerte De Sécurité sur Compact Suction Unit

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

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
    2015-04-27
  • Date de publication de l'événement
    2015-04-27
  • 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_20150427b.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: laerdal compact suction unit medical device manufacturer, laerdal, has issued a medical device safety alert concerning its laerdal compact suction unit [model number: 88005103 and 88006103; serial numbers: 150303a0479 to 150303a0493]. a limited number of laerdal compact suction unit 4 units placed on the market have been manufactured with a material that does not meet its specification. all affected units have passed the functional test performed before release and are capable of achieving maximum vacuum. however, lifetime and performance at operating temperature limits (high/ low temperatures) is unknown. therefore, the units with serial numbers listed above must be returned to the manufacturer. units with affected serial numbers must be removed from use. 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 27 april 2015.

Device

Compact Suction Unit
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Laerdal Compact Suction Unit
  • Manufacturer
    Laerdal

Manufacturer

Laerdal