Events

Retiro De Equipo (Recall) de Device Recall TotalCare 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
    65259
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1794-2013
  • Fecha de inicio del evento
    2013-05-30
  • Fecha de publicación del evento
    2013-07-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118400
  • 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, flotation therapy, powered - Product Code IOQ
  • Causa
    When the bed is put into the chair egress position, the magnets on the mattress may not hold the bottom of the mattress flat to the bed frame, and the mattress foot section will extend away from the bed at an angle. a patient attempting to get back into the bed may miss the seat and sit on the foot section instead. the patient can slide down to the floor, or fall, with possible injury.
  • Acción
    The firm, Hill-Rom, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 29, 2013 was sent to all consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Until the correction is implemented, after placing the bed into chair position, regularly check the foot section of the mattress. If necessary, push it back against the bed frame until the magnets hold it in place before allowing the patient to get back into or out of bed. In addition, forward a copy of this letter to any other facility personnel you deem appropriate. If you have any questions concerning this notification, please contact your distributor, your Hill-Rom representative, or Hill-Rom Technical Support at 800-445-3720 (Mon-Thurs, 8 am-6:30 pm; Friday, 8 am-6 pm).

Device

Device Recall TotalCare Bed
  • Modelo / Serial
    Bed model numbers: PAU001010784, PAU005010784, P1900, PAK169N10184, PAK169N10384, PA8171210184, PA8175210184, PA8175210384, PA8171210384, PA8171310384, and PA8173210384.   The AccuMax Quantum VPC, Complete and Convertible mattresses are not serialized, but were distributed between September 2005 and April 2013
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries of: Canada, Colombia, Nigeria, Kuwait and Saudi Arabia.
  • Descripción del producto
    TotalCare Bed used with AccuMax Quantum VPC mattress || AccuMax Quantum Complete mattress, and AccuMax Quantum Convertible mattress || The TotalCare Bed System is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.
  • 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