Events

Retiro De Equipo (Recall) de Device Recall ArjoHuntleigh Flowtron ACS900

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. dba ArjoHuntleigh.

¿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
    77551
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2714-2017
  • Fecha de inicio del evento
    2017-06-14
  • Fecha de publicación del evento
    2017-06-26
  • 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=156467
  • 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
    Sleeve, limb, compressible - Product Code JOW
  • Causa
    Reports of the device failure involving delivering continuous pressure to the calf garment and not deflating as intended, without triggering an alarm.
  • Acción
    ArjoHuntleigh sent a Field Safety Notice and Customer Response form to affected customers describing the reason for the recall and the actions to be taken. The instruction to customers is to review the Field Safety Notice and complete the Customer Response Form to acknowledge receipt and understanding of the Field Safety Notice and the required actions. These actions taken are as follows: 1. Ensure that all caregivers and users of the ArjoHuntleigh Flowtron ACS900 pump are made aware of this Field Safety Notice (FSN) and all listed devices at facility are available to be upgraded to software version V2.000 during the service technician visit. 2. Complete and sign the enclosed Customer Response Form and return this form to the local ArjoHuntleigh office. Note: ArjoHuntleigh will contact the designated facility representative listed on the Customer Response Form to schedule service to upgrade the software on all listed devices at your facility, free of charge. The device may stay in use until the upgrade will be performed, on the condition that the patients limbs are monitored frequently and the garments are checked to ensure that they are correctly fitted to the patient and that deflation of the garments is occurring on a regular basis. It is also recommended that the pump LCD display is regularly checked to ensure that it shows that the garments are inflating and deflating correctly (in the limited number of complaints, the LCD display was blank). This Field Safety Notice must be distributed to those individuals who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Additionally they should maintain awareness of the notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. The letter states that if the customer has additional questions or they require assistance completing the Customer Response Form, they should contact ArjoHu

Device

Device Recall ArjoHuntleigh Flowtron ACS900
  • Modelo / Serial
    Model numbers: 526000-01, 526000-01P, 526000-02, 526000-02P. Serial numbers range from 1400028031 to 1600048470.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (Nationwide) and internationally to the following countries: United Kingdom, Australia, New Zealand, Japan, Italy, United Arab Emirates, France, Canada, Brazil, Austria, Saudi Arabia, Qatar, India, Switzerland, Bahrain, Kuwait, South Africa, Lebanon, Netherlands, Poland, Spain, Ecuador, Hong-Kong, Colombia, Malaysia, Paraguay, Mauritius, Cyprus, Greece, Oman, Norway, Ireland, Pakistan, Czech Republic, Mexico, Sweden, Tanzania, Hungary, Singapore, Jordan, Israel, Denmark, Chile, and Germany.
  • Descripción del producto
    ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 || Device is used to prevent the occurrence of Deep Vein Thrombosis (DVT) in at-risk patients. The system must be used as part of a prescribed plan of car under the supervision of trained medical and/or Clinical staff. The system is intended for use only in professional healthcare facilities. It is not intended to be used in the home healthcare environment.
  • Manufacturer
    Arjo, Inc. dba ArjoHuntleigh

Manufacturer

Arjo, Inc. dba ArjoHuntleigh
  • Dirección del fabricante
    Arjo, Inc. dba ArjoHuntleigh, 2349 W Lake St, Addison IL 60101-6183
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA