Events

Alerte De Sécurité sur Kendall 1010P Multi-Function Defibrillation Electrodes & Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes

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

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
    2014-09-29
  • Date de publication de l'événement
    2014-09-29
  • 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_20140929a.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: covidien llc kendall 1010p multi-function defibrillation electrodes & medi-trace cadence adult multi-function defibrillation electrodes the australia therapeutic goods administration (tga) and the health canada posted medical device safety alerts concerning kendall 1010p multi-function defibrillation electrodes [model no.:22660pc, 22660r] & medi-trace cadence adult multi-function defibrillation electrodes [model no.: 40000006] manufactured by covidien llc. according to the medical device safety alerts, there was incompatibility between the philips automated external defibrillators (aed) models fr3 and frx defibrillators and covidien medi-trace cadence and kendall defibrillation electrodes. these electrodes will not connect with philips fr3 and frx aed units, and in the case of the use of covidien defibrillation electrodes with the philips fr3 aed units, could result in a delay of therapy. the frx aed unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. the manufacturer is modifying the labeling to clarify that use of the affected electrodes are incompatible with certain aed units. for details, please refer to the following health canada and tga websites: http://www.Healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2014/41547r-eng.Php http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-01034-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 29 sep 2014.

Device

Kendall 1010P Multi-Function Defibrillation Electrodes & Medi-Trace Cadence Adult Multi-Function ...
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Description du dispositif
    Medical Device Safety Alert: Covidien LLC Kendall 1010P Multi-Function Defibrillation Electrodes & Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes
  • Manufacturer
    Covidien LLC

Manufacturer

Covidien LLC
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH