Events

Alerte De Sécurité sur Defibrillator/pacer SLIM corpuls3

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

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
    2014-09-17
  • Date de publication de l'événement
    2014-09-17
  • 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_20140917.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: device technologies defibrillator/pacer slim corpuls3 the australia therapeutic goods administration (tga) posted a medical device safety alert concerning defibrillator/pacer slim corpuls3 (product code: cp-4301) manufactured by device technologies. according to the alert, there is the possibility that a component on that circuit board could be damaged mechanically due to too little distance between a circuit board and the housing. this impairs the radio connection between the modules. the user can recognise this, if a respective error message (ie. “no connection to defibrillator unit” or “no connection to p-box”) is displayed. in rare cases this can result in impairment of the radio connection between the modules, and then it is no longer possible to: a) perform full patient monitoring; and b) correctly adjust and operate a therapy function of the device. vibrations have been found to increase the likelihood of this malfunction. due to this issue, diagnosis and therapy are delayed, because the measurement and therapy functions cannot perform without problems. the manufacturer is advising the customer to connect the module mechanically to form a compact device if the error message is displayed. a permanent correction of the error is only possible by replacing the affected radio module. the manufacturer is arranging replacement of the radio module. for details, please refer to tga website http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00979-1 if you are in possession of the product, please contact your supplier for necessary actions. posted on 17 september 2014.

Device

Defibrillator/pacer SLIM corpuls3
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Device Technologies Defibrillator/pacer SLIM corpuls3
  • Manufacturer
    Device Technologies

Manufacturer

Device Technologies