Events

Retiro De Equipo (Recall) de Device Recall Maxi Sky 1000 and BHM Medical V10 Bariatric Ceiling Lift

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
    58048
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1983-2011
  • Fecha de inicio del evento
    2011-03-21
  • Fecha de publicación del evento
    2011-04-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98101
  • 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 battery-powered control board in the ceiling lift motor may overheat, resulting in smoke and possibly flames and the lift becoming inoperable.
  • Acción
    ArjoHuntleigh sent an Urgent Field Safety Notice dated March 4, 2011, to all affected customers via UPS Ground on March 21, 2011. The notice informed the accounts of the potential for smoke and flames coming out of the Maxi Sky 1000/V10 bariatric ceiling lifts. The accounts were requested to immediately cease use of the affected lifts, powering them down by activating the emergency stop, and tag the lifts to prevent further use. If there is a clinical need to continue use of the lift before it is retrofitted or replaced, specific instructions were given to reduce the risk of a device malfunction. The accounts were requested 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 Maxi Sky 1000 and BHM Medical V10 Bariatric Ceiling Lift
  • Modelo / Serial
    Model numbers LF20010, LF20011, LF20013, LF20014, LF20015, LF21015, LF21019, 9120001, 9120004, 9120005, 9120008, 9120009 and 9121009. All serial numbers manufactured prior to February 1, 2011.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Maxi Sky 1000/BHM Medical V10 Bariatric Ceiling Lift System; a patient transfer lift; ArjoHuntleigh, Addison, IL 60101; Model numbers LF20010, LF20011, LF20013, LF20014, LF20015, LF21015, LF21019, 9120001, 9120004, 9120005, 9120008, 9120009 and 9121009 || The Maxi Sky 1000 is designed for lifting patients in a homecare setting, at nursing homes and other assisted living centers, as well as in institutional or hospital settings. Patient transferring is performed under the supervision of an appropriately trained caregiver staff, in accordance with the instructions for use. All other uses must be avoided.
  • 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