Events

Retiro De Equipo (Recall) de Device Recall Arjo Ambulift Classic

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 Arjo, 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
    47885
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1651-2008
  • Fecha de inicio del evento
    2008-05-05
  • Fecha de publicación del evento
    2008-08-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-02-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70439
  • 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
    Lift, Patient, Non-AC powered - Product Code FSA
  • Causa
    The armrests of the lift chair may push up, allowing the patient to slip down and out of the seat. the resultant fall could result in serious or fatal patient injuries.
  • Acción
    Arjo sent Customer Field Correction Notification letters dated 5/2/08 on the Arjo letterhead to the end user accounts who received the affected Ambulift Patient Lifts, to the attention of the Administrator/Risk Manager, via UPS 2nd day delivery on 5/5/08. The letters informed the consignees of the incident with the patient slipping from the seat of the lift and sustaining fatal injuries and advised them to always ensure that a clinical assessment to verify that the resident has sufficient upper body strength to maintain a steady position on the chair, and that the resident has sufficient mental capacity to adhere to the caregiver's instructions, is carried out by a qualified nurse or therapist before lifting residents with the Ambulift. To further enhance safety, a seat belt is being made available, which must be fitted to the chair, enabling it to be used when required by clinical assessment. Instructions on how to apply, use, and maintain the seat belt will be provided with the belts. The belts will be provided at no cost. The accounts were requested to review, complete and return the enclosed customer response form, indicating the number seat belts needed. Any questions were directed to Arjo's Quality Department at 1-800-323-1245, ext. 6140 or 6165.

Device

Device Recall Arjo Ambulift Classic
  • Modelo / Serial
    Models AKDB1890-04US and AKDB1895-04US, all serial numbers
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA includes the states of AL, AZ, DE, FL, KY, MO, NY, OK, and VA
  • Descripción del producto
    Ambulift Classic, battery powered patient lift. The Ambulift is used to move and lift patients from their beds, transport them to the bathroom, and lift them in and out of the bath. || Model KDB1890-04US - Ambulift Classic with chair and leg rest. || Model KDB1895-04US - Ambulift Classic with chair, leg rest and scale.
  • Manufacturer
    Arjo, Inc.

Manufacturer

Arjo, Inc.
  • Dirección del fabricante
    Arjo, Inc., 50 Gary Ave Ste A, Roselle IL 60172-1684
  • Source
    USFDA