Events

Alerte De Sécurité sur cardioLife defibrillator, TEC-5521K and TEC-5531K

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

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
    2012-11-14
  • Date de publication de l'événement
    2012-11-14
  • 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_20121114.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: nihon kohden cardiolife defibrillator, tec-5521k and tec-5531k the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning a potential malfunction of cardiolife defibrillator (model tec-5521k and tec-5531k) using a software version ≦ 01-20, manufactured by nihon kohden corporation. during operation the defibrillator in battery mode there are several battery alarms when reaching critical levels of the battery capacity. when the battery alarms are ignored and the battery is discharged continuously, the defibrillator shut down automatically. in rare cases this could lead to a damage of the power control circuit and the defibrillator could not turn on either in battery mode nor in ac power mode again. this defect requires maintenance of the defibrillator by the authorized service partner. the frequency of the reported incidences caused by this malfunction is approx. 0.017%. the manufacturer advised users to make sure that the battery of the defibrillator is charged completely always and that the battery test and the exchange of the battery is performed regularly according the instructions in the operator’s manual and follow the instructions related to the battery alarms. this avoids the automatically shut-down of the defibrillator. also, the manufacturer will eliminate this potential malfunction to the affected defibrillators by the installation of a software upgrade with an improved algorithm for the automatically shut-down of the defibrillator when the battery is discharged completely. this software upgrade will be installed by the manufacturer during the next regularly maintenance. for details, please refer to the mrha website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con203860 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 14 november 2012.

Device

cardioLife defibrillator, TEC-5521K and TEC-5531K
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Nihon Kohden cardioLife defibrillator, TEC-5521K and TEC-5531K
  • Manufacturer
    Nihon Kohden Corporation

Manufacturer

Nihon Kohden Corporation