Events

Alerte De Sécurité sur BeneHeart D1 Defibrillator/ Monitor

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

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
    2014-11-18
  • Date de publication de l'événement
    2014-11-18
  • 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_20141118b.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: beneheart d1 defibrillator/ monitor the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning beneheart d1 defibrillator/ monitor, manufactured by mindray. the affected product is beneheart d1 with the first four digits of the serial number as fq37/ fq38/ fq39/ fq3a/ fq3b/ fq3c/ fq41/ fq42/ fq43/ fq44/ fq45/ fq46/ fq47. the manufacturer has identified the affected aeds might fail to boot. when this issue occurs, the status indicator of the aed is off. the reason for the startup failure of the aed is due to abnormal reset of the power management circuit on the main control board. the manufacturer advises affected users to discontinue use of the aed. the manufacturer will repair the affected aeds as soon as possible. for details, please refer to the following link: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con473632 according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 18 november 2014.

Device

BeneHeart D1 Defibrillator/ Monitor
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: BeneHeart D1 Defibrillator/ Monitor
  • Manufacturer
    Mindray

Manufacturer

Mindray