Events

Retiro De Equipo (Recall) de Device Recall Welch Allyn AED 20 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
    35587
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1106-06
  • Fecha de inicio del evento
    2006-06-15
  • Fecha de publicación del evento
    2006-06-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-07-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46430
  • 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
    Defibrillator - Product Code MKJ
  • Causa
    The welch allyn aed 20 defibrillators may display a 'defib comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ecg and deliver the appropriate therapy.
  • Acción
    MRL issued a press release on 6/15/06, and began sending Urgent Medical Device Recall letters on the same date to the direct accounts informing them of the possibility of the defibrillator going into a terminal failure due to a U25 IC socket susceptible to defibrillation circuit board communication errors. The accounts were asked to respond to the notification witihin 5 working days by faxing or mailing the enclosed response form, or calling Welch Allyn-MRL Technical Support at 1-800-462-0777. A loaner AED 20 will then be sent to the consignee with instrucitons on how to return their unit for correction.

Device

Device Recall Welch Allyn AED 20 Defibrillator
  • Modelo / Serial
    Model AED20, catalog #972211, 972212, 972213, 972214, 972215 and 972216; serial numbers 205199 through 205786, except for 205213, 205236, 205237, 205238, 205239, 205240, 205242, 205243, 205247, 205307, 205308, 205309, 205465, 205653, 205654, 205656, 205664, 205665, 205667, 205669, 205677, 205678, 205684, 205703, 205708, 205719, 205732, 205736, 205754, 205756, 205760, 205762, 205763, 205764, 205767, 205774, 205775, 205777, 205781, 205782, 205784.  Also included in the recall are serial numbers 201784, 202804, 205179, 205790, 205806, 205808, 205818, 205842, 205866, 206076, 206078, 206079, 206080, 206081, 206096, 206125, 206131, 206137, 206138, 206140, 206162, 206164, 206175, 206177, 206180, 206216, 207511, 207518, 207520, 207521, 207522.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide-including USA, Australia, Canada, China, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Nicaragua, Norway, Poland, Portugal, Singapore, Slovenia, South Africa, South Korea, Spain, Switzerland, United Arab Emirates and the United Kingdom.
  • Descripción del producto
    Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED20, part 972200
  • 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