Events

Retiro De Equipo (Recall) de Rose Bed

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 Stryker Medical Division of Stryker Corporation.

¿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
    66137
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0363-2014
  • Fecha de inicio del evento
    2013-10-23
  • Fecha de publicación del evento
    2013-11-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-05-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121538
  • 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
    Bed, ac-powered adjustable hospital - Product Code FNL
  • Causa
    It was reported that the siderail may appear latched when it is not, due to lack of proper preventive maintenance. this might result in bruises and/or lacerations to a patient who is leaning against the siderails if the siderail releases. additionally, the siderail may not effectively constrain a patient to prevent them from rolling or falling off the bed.
  • Acción
    Stryker Medical sent a Medical Device Notification letter dated October 23, 2013, to all affected consignees. The letter described the recalled product, potential injuries associated with the side rail sticking, as well as providing preventive measures to be taken to mitigate the risk. Consignees were directed to locate the beds listed in this notice, ensure that the siderails have been inspected and adjusted, as required, continue to routinely inspect the siderails and functionality using the enclosed, enhanced product maintenance information. Problems and concerns should be addressed to Stryker at (1-800-327-0770, option 2). Consignees were asked to Fax (269-488-8691) or e-mail (ProductFieldAction@stryker.com ) the enclosed return form and directed to forward the notice if product was further distributed and advise Stryker of the beds new location. For questions regarding this recall call 269-324-6609.

Device

Rose Bed
  • Modelo / Serial
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Canada; Japan, South America, Latin America and China.
  • Descripción del producto
    Model FL14E Rose || BedsThe Rose Bed is an AC-powered adjustable long-term care bed intended for medical purposes that consists of a bed with a built-in motor and controls that can be operated to adjust the height and surface contour of the bed. The device includes movable and latchable siderails
  • Manufacturer
    Stryker Medical Division of Stryker Corporation

Manufacturer

Stryker Medical Division of Stryker Corporation
  • Dirección del fabricante
    Stryker Medical Division of Stryker Corporation, 3800 E Centre Ave, Portage MI 49002-5826
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA