Events

Alerte De Sécurité sur Medi-Trace Cadence Adult and Pediatric Radiotransparent 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.

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
    2013-04-23
  • Date de publication de l'événement
    2013-04-23
  • 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_20130423a.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 medi-trac cadence adult and pediatric radiotransparent defibrillation electrodes the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device field safety concerning medi-trac cadence adult (product id 22550r)and pediatric (product id 22550p) radiotransparent defibrillation electrodes, manufactured by covidien. the affected lot numbers are as follows: product id 22550r: 226543x, 230814x, 232182x, 234245x, 235641x, 300446x and 305320x product id 22550p: 228651,232146, 235646x,301833x and 303928x covidien has received customer reports of arcing/sparking on the defibrillation electrode lead wire. the manufacturer has become aware that the vendor who supplies covidien with the wire/connector subassembly experienced equipment damage due to misalignment from tooling installed in aug 2012. this could result in arcing, sparking, or thermal damage to the lead wire, which could render the device incapable of delivering the appropriate energy or shock to the patient. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con261823 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 april 2013.

Device

Medi-Trace Cadence Adult and Pediatric Radiotransparent Defibrillation Electrodes
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Covidien Medi-Trac Cadence Adult and Pediatric Radiotransparent Defibrillation Electrodes
  • Manufacturer
    Covidien

Manufacturer

Covidien
  • 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