Events

Retiro De Equipo (Recall) de Covidien MediTrace Cadence Pediatric Radiotransparent Defibrillation Electrode

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Covidien LLC.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    64868
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1185-2013
  • Fecha de inicio del evento
    2013-04-08
  • Fecha de publicación del evento
    2013-04-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-11-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117215
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Pacemaker, cardiac, external transcutaneous (non-invasive) - Product Code DRO
  • Causa
    Defibrillation electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy or shock to the patient.
  • Acción
    Covidien sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 8, 2013 to all affected customers. The letter identifies the product, problem and requests that customers immediately stop using and segregate any affected product from inventory. Questions:Call 1-800-962-9888 option 8, then extension 2500.

Device

Covidien MediTrace Cadence Pediatric Radiotransparent Defibrillation Electrode
  • Modelo / Serial
    Lot Numbers: 228651, 232146, 235646X, 301833X, 303928X
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Korea, Japan, Canada, Australia, Brazil, Belgium, Singapore, and South Africa.
  • Descripción del producto
    Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode || Product ID: 22550P. || Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
  • Manufacturer
    Covidien LLC

Manufacturer

Covidien LLC
  • Dirección del fabricante
    Covidien LLC, 15 Hampshire Street, Mansfield MA 02048-1113
  • 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
    USFDA