Events

Retiro De Equipo (Recall) de Welch Allyn AED 10 Defibrillator

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 MRL, Inc., A Welch Allyn Company.

¿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
    28880
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0918-04
  • Fecha de inicio del evento
    2004-04-26
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-11-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32679
  • 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 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 data.
  • Notas adicionales en la data
    unknown device name - Product Code MKJ--
  • Causa
    A faulty component has been identified which could result in an intermittent shock button (button #3) failure on the aed10 defibrillator.
  • Acción
    Urgent Medical Device Recall letters dated 4/26/04 were sent to the end users via certified mail on 4/26/04. The letters informed the users of the intemittent shock (fire or 3) button failure on the AED 10. The letters included a list of the affected serial numbers, and requested the users to call Welch Allyn MRL Technical Support as soon as possible at 1-800-462-0777 for a replacement AED 10 and to answer any questions. A replacement AED 10 will be sent to the end users within 10 days, and the users were requested to return their AED 10 in the same shipping box accompanying the replacement unit. A follow-up letter will accompany the replacement unit with instructions on how to verify the affected units, packing instructions for the return of the affected units to Welch Allyn MRL, and a correction response form to be completed and enclosed with the returned unit.

Device

Welch Allyn AED 10 Defibrillator
  • Modelo / Serial
    part numbers 970300 and 970302; serial numbers 4613, 4888/4891, 4897, 6369/6386, 6396/6704, 6706, 6709/6743, 6745/6803, 6806, 6807, 6809, 6811, 6813/6832, 6836/6838, 6853/6855, 6912, 6914, 6917, 6921, 6922, 6924/6926
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Nationwide, and internationally to the United Kingdom, Ireland, Singapore, France and South Africa.
  • Descripción del producto
    Welch Allyn AED 10 Defibrillator; a battery powered automated external defibrillator; Manufacturer: MRL, Inc., A Welch Allyn Company, 100 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED10, part numbers 970300 (defibrillator) and 970302 (defibrillator with soft shell carrying case)
  • Manufacturer
    MRL, Inc., A Welch Allyn Company

Manufacturer

MRL, Inc., A Welch Allyn Company
  • Dirección del fabricante
    MRL, Inc., A Welch Allyn Company, 1000 Asbury Dr Ste 17, Buffalo Grove IL 60089-4551
  • Source
    USFDA