Events

Retiro De Equipo (Recall) de Device Recall Enterprise 9000 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 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
    63187
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0477-2013
  • Fecha de inicio del evento
    2012-11-16
  • Fecha de publicación del evento
    2013-08-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-09-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112872
  • 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
    Arjohuntleigh has received reports of unintended movement where the backrest and/or thigh sections of the bed have moved without anyone consciously pressing the control button. these incidents have occurred in high dependency and intensive therapy environments where unintended movement of the patient may have serious consequences.
  • Acción
    Please be aware that this is not a new recall. Posting to the Internet was delayed due to a technical error. ArjoHuntleigh sent an Urgent Field Correction Recall letters dated November 16, 2012, to all affected customers, informing the accounts of reports of unintended movement of the backrest and/or thigh sections of the bed without intentional activation of the control buttons, which could have serious consequences due to the patient's links to other life supporting devices. The accounts were requested to disseminate the information to all users of the affected beds, to attach the enclosed warning labels to the outside of both head end safety sides immediately adjacent to the controls, to include a copy of the notice in the Instruction for Use Manuals for their beds, and to complete the Customer Response Form online, using the enclosed card's instructions. Questions were directed to the ArjoHuntleigh at 1-800-323-1245, ext 57985.

Device

Device Recall Enterprise 9000 Bed
  • Modelo / Serial
    Models 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800; all serial numbers
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide, including Puerto Rico) and the countries of Algeria, Angola, Australia, Austria, Bahrain, Belgium, Bosnia and Herzegovia, Botswana, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, Falkland Islands, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahira, Lithuania, Malaysia, Malta, Mauritius, Mexico, Morocco, the Netherlands, New Zealand, Nigeria, Nordic, Norway, Oman, Panama, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Switzerland, Syrian Arab Republic, Thailand, Turkey, United Kingdom, United Arab Emirates, Uruguay, Venezuela and Yemen.
  • Descripción del producto
    Enterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in electronic weigh scale, patient bed exit alarm, and under bed anti-entrapment system; ArjoHuntleigh AB, Eslov, Sweden; Models 9000, 9600, 9700 and 9800 || General medicine, general and specialist surgery, care of the elderly, HDU, ITU, coronary care and oncology. The bed is appropriate for high dependency patients who pose a movement and handling risk and/or whose clinical condition requires that they are positioned with the minimal physical handling.
  • 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