Events

Retiro De Equipo (Recall) de Device Recall Edwards' MHANM8 Pressure Slave Cable

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 Edwards Lifesciences, 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
    56148
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0160-2011
  • Fecha de inicio del evento
    2010-06-25
  • Fecha de publicación del evento
    2010-10-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-05-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92746
  • 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
    Computer, diagnostic pre-programmed, single-function - Product Code DXG
  • Causa
    The recall was initiated because the edwards' mhanm8 pressure slave cable was wired incorrectly, thus will not work as stated.
  • Acción
    Edwards Lifesciences contacted customers via telephone on June 22, 2010 informing them of the product, the problem and the action they should take. Customers were asked to locate their cables and send them back overnight using the provided Edwards FedEx account number. Edwards Lifesciences indicated their personnel would follow-up with each customer until all units were returned. For any questions regarding this recall call (949) 250-2007.

Device

Device Recall Edwards' MHANM8 Pressure Slave Cable
  • Modelo / Serial
    Lot Numbers: 58822824; 58821774
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including CA, PA, and MI and the countries of Switzerland and Thailand
  • Descripción del producto
    Edwards' MHANM8 Pressure Slave Cable, Part Number:693657001 || The Edwards Lifesciences Analog Slave Cable is used to transfer monitoring output from patient monitors to the analog input ports of the Vigileo Monitor series or compatible Edwards monitoring systems. This cable has instrument specific connectors.
  • Manufacturer
    Edwards Lifesciences, Llc

Manufacturer

Edwards Lifesciences, Llc
  • Dirección del fabricante
    Edwards Lifesciences, Llc, 1 Edwards Way, Irvine CA 92614-5688
  • Source
    USFDA