Events

Retiro De Equipo (Recall) de Device Recall ArjoHuntleigh

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 ARJOHUNTLEIGH POLSKA Sp. z.o.o..

¿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
    68594
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2693-2014
  • Fecha de inicio del evento
    2014-07-28
  • Fecha de publicación del evento
    2014-09-24
  • 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=128286
  • 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
    Arjohuntleigh received three reports where the bolt under the scale unscrewed from the scale. there is a remote risk concerning the bolt unscrewing from the scale. when the scale and bolt parts are not correctly serviced, or when they receive a sharp blow during or outside of use, it is possible the bolt holding the spreader bar to the scale could unscrew during subsequent use. as a result, the sp.
  • Acción
    ARJOHUNTLEIGH sent an URGENT - FIELD SAFETY NOTICE letter dated July 28, 2014 to all customers. The letter identified the affected product, problem and actions to be taken. The letters provided customers with two options with how to address this recall: 1) because the devices are close to their 10-year lifetime, customers can return the devices for a trade-in discount that will be applied to the purchase of a new ArjoHuntleigh patient transfer lift; or 2) an ArjoHuntleigh Service Technician will install a new scale with added locking features to the existing unit free of charge. Customers were further instructed to: 1) ensure that all caregivers and users of the devices are given a copy of the letter; 2) place a copy of this letter with the device's instruction for use; and, 3) to complete and return the enclosed Customer Service Response form. For questions or assistance completing the Customer Response Form, please contact ArjoHuntleigh at 1-800-323-1245, ext. 57985 during office hours; Monday to Friday, 8:00am to 5:00pm (CST) or via email at AHNA-RA@arjohuntleigh.com.

Device

Device Recall ArjoHuntleigh
  • Modelo / Serial
    Model Numbers: HMA0002 and HMB002-US;  Serial Numbers: MPLAT0409W1177 ; MPLAT0410W1213 ; MPLAT0410W1228 ; MPLAT0410W1229 ; MPLAT0410W1231 ; MPLAT0410W1232 ; MPLAT0412W1290 ; MPLAT0412W1296 ; MPLAT0412W1297 ; MPLAT0502W1403 ; MPLAT0502W1404 ; MPLAT0503W1485 ; MPLAT0503W1486 ; MPLAT0504W1518 ; MPLAT0504W1519 ; MPLAT0504W1520 ; MPLAT0504W1531
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the state of MA and the countries of Australia, Germany, and Italy.
  • Descripción del producto
    Minstrel (with scale) || Product Usage: is a mobile passive hoist. It is intended for lifting and transporting adult residents on horizontal floors in hospitals, nursing homes or other health care facilitates. The Minstrel device aids in the lifting, transfer and lowering to safe position, of a patient. This is accomplished by placing a sling under the patient, and attaching the sling to a spreader bar that is connected to a lifting arm jig via a connection to the spreader bar that allows a swiveling up-down movement. Using battery power, an actuator then powers the lifting arm upwards so that the patient in the sling is lifted from, typically, a bed or chair.
  • Manufacturer
    ARJOHUNTLEIGH POLSKA Sp. z.o.o.

Manufacturer

ARJOHUNTLEIGH POLSKA Sp. z.o.o.
  • Dirección del fabricante
    ARJOHUNTLEIGH POLSKA Sp. z.o.o., UI. KS. PIOTRA WAWRZYNIAKA 2, KOMORNIKI Poland
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA