Events

Retiro De Equipo (Recall) de Device Recall LIFEPAK

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 Medtronic Emergency Response Systems, Inc..

¿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
    31111
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0562-05
  • Fecha de inicio del evento
    2005-02-03
  • Fecha de publicación del evento
    2005-03-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-08-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37172
  • 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
    Automated External Defibrillators (Non-Wearable) - Product Code MKJ
  • Causa
    Potential to not detect patients at the low end of the patient impedance range.
  • Acción
    On 2/3/05 the firm issued a 'Medical Device Correction' letter dated January 2005 to their customers. The letter advised customers of the issue and stated a representative from the firm would visit each facility to update affected unit. On 2/25/05 a nationwide press release was issued. On 3/1/05 the firm began telephoning each customer, this was followed by another letter titled MEDICAL DEVICE RECALL. The letter advises of the issue and recommends defibrillators remain in service when no alternative is available until the unit can be corrected. Each unit will be replaced or corrected. On 4/22/05 the firm issued another letter, via certified mail return receipt, expanding their recall. Letter was issued to all customers affected by the expansion of the recall. On 4/22/05 the firm issued a press release advising of the expansion of the recall. The firm's web site also provides a listing of affected units.

Device

Device Recall LIFEPAK
  • Modelo / Serial
    Serial numbers - various, noncontiguous Part numbers - 3005400-XXX, D3005400-XXX, U3005400-XXX
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Devices were distributed to 750 domestic consignees dn 16 international consignees.
  • Descripción del producto
    LIFEPAK 500 AED.
  • Manufacturer
    Medtronic Emergency Response Systems, Inc.

Manufacturer

Medtronic Emergency Response Systems, Inc.
  • Dirección del fabricante
    Medtronic Emergency Response Systems, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • Source
    USFDA