Events

Retiro De Equipo (Recall) de Device Recall Progressa 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 Hill-Rom, 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
    79516
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1319-2018
  • Fecha de inicio del evento
    2018-01-12
  • Estado del evento
    Open, Classified
  • 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=162541
  • 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
    A component used within the braking system may break resulting in one or more brake pedals on the bed staying in brake or not being engaged which could result in unwanted bed movement and possible patient or user injury.
  • Acción
    Firm has developed a correction for the braking system and plan to have a Hill-Rom technician to update affected Progressa Beds. Hill-Rom sent a letter, dated January 12, 2018. Until beds are updated, follow the safety information as outlined in the Progressa User manual each time when setting the brakes. Warning: Always set the brakes when the bed is occupied, except during patient transport. To help make sure the bed will not move, push and pull on the bed to check it after the brakes are engaged. Brakes should always be set when the bed is occupied and especially when moving a patient from one surface to another. Patients often use the bed for support when getting out of bed and could be injured if the bed unexpectedly moves. After setting the brakes, push and pull the bed to make sure of stability. If the brakes do not hold after following the instructions above, take the bed out of service until the bed is updated.

Device

Device Recall Progressa Bed
  • Modelo / Serial
    S159AW9192 through S305AW2321 Beds manufactured from June 8, 2017 to November 1, 2017
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution. US nationwide, Canada, Chile, Colombia, Costa Rica, France, Hong Kong, Israel, Jamaica, Japan, Jordan, Malaysia, Mexico, Oman, Panama, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, UAE, and UK.
  • Descripción del producto
    Progressa Bed - AC-powered adjustable hospital bed
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

Hill-Rom, Inc.
  • Dirección del fabricante
    Hill-Rom, Inc., 1069 State Road 46 E, Batesville IN 47006-7520
  • Empresa matriz del fabricante (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA