Events

Alerte De Sécurité sur maquet heart-lung machine hl 30

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

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
    2013-02-08
  • Date de publication de l'événement
    2013-02-08
  • 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_20130208.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: maquet heart-lung machine hl 30 medical device manufacturer, maquet cardiopulmonary ag issued a medical device safety alert concerning heart-lung machine hl 30. the manufacturer has identified two potential issues with the hl30 devices which will be addressed in a software upgrade: first, in rare instances, as a result of an accidental impact or 'bump' to the pump head cover, the unit may stop. this stoppage is intended to occur by design, whenever the pump head cover is opened during operation. however, if the impact is rapid, the unit may stop without an informational message explaining the reason behind. second, there is a software anomaly in the cardioplegia module whereby, in a limited number of cases, the unit slave pump did not engage after cardioplegia pause. no patient injury has been reported in either issue. the local supplier confirmed that the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 8 february 2013.

Device

maquet heart-lung machine hl 30
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: MAQUET Heart-lung Machine HL 30
  • Manufacturer
    MAQUET Cardiopulmonary AG

Manufacturer

MAQUET Cardiopulmonary AG