Events

Alerta De Seguridad para Medi-Trace Cadence Adult and Pediatric Radiotransparent Defibrillation Electrodes

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Covidien.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2013-04-23
  • Fecha de publicación del evento
    2013-04-23
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130423a.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Covidien Medi-Trac Cadence Adult and Pediatric Radiotransparent Defibrillation Electrodes
  • Manufacturer
    Covidien

Manufacturer

Covidien
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “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