Events

Retiro De Equipo (Recall) de Natus Warmette Blanket Cabinet and Warmette Dual Cabinet

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 Natus Manufacturing Limited.

¿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
    75846
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0951-2017
  • Fecha de inicio del evento
    2016-10-15
  • Estado del evento
    Completed
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151447
  • 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
    Warmer, thermal, infusion fluid - Product Code LGZ
  • Causa
    The fuse blows during initial power up or after a period of time. this results in a complete loss of power to the cabinet and in some cases has resulted in the fuse cover for the power inlet melting slightly.
  • Acción
    Natus Manufacturing Limited sent an "Urgent Field Safety Notice" letter dated April, 2016, via email. The letter described the problem and the product involved in the recall. Informed the consignees that a repair kit to correct the issue is available for repair of affected units. Requested consignees to complete the attached form and Faxto 847-949-6031 or e-mail it to Natus Quality Programs. In turn the firm will send the repair kit. For questions contact Technical Service at 888-496-2887. For questions regarding this recall call 888-496-2887.

Device

Natus Warmette Blanket Cabinet and Warmette Dual Cabinet
  • Modelo / Serial
    Warmette Blanket Cabinet Serial Numbers: 10216709, 10216711, 10218559, 10219214, 10219337, 10219338, 10219339, 10219340, 10219387, 10219388, 10219869, 10219870, 10219871, 10219872, 10219873, 1028880.   Warmette Dual Cabinet Serial Numbers: 10216713, 10216714, 10218500, 10218501, 10218522, 10218526, 10218528, 10218982, 10219257, 10219389, 10219390, 10220534, 10220536, 10220537, 10220538.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including NJ, NC, TX, IL, VA, NY, FL, CA, MS, WA, IN, and MA. and Internationally to Canada and Costa Rica.
  • Descripción del producto
    Natus Warmette Blanket Cabinet and Warmette Dual Cabinet || The Natus Warmette Blanket Cabinet is designed to store and warm blankets and hospital linens; while, the Natus Warmette Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment and fluids (irrigation and/or injection) in the other compartment within the storage times and warming temperatures recommended by the manufacturers of those items
  • Manufacturer
    Natus Manufacturing Limited

Manufacturer

Natus Manufacturing Limited
  • Dirección del fabricante
    Natus Manufacturing Limited, IDA Business Park, GORT, Galway Ireland
  • Empresa matriz del fabricante (2017)
    Natus Medical Incorporated
  • Source
    USFDA