Events

Retiro De Equipo (Recall) de Maquet Universal Frame for Positioning Patients

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 Maquet Cardiovascular Us Sales, Llc.

¿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
    71998
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0248-2016
  • Fecha de inicio del evento
    2015-08-17
  • Fecha de publicación del evento
    2015-11-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139573
  • 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
    Accessories, operating-room, table (kit) - Product Code FWZ
  • Causa
    Two serious thromboembolic events were reported involving the adjustable positioning elements (part number 1007.28a0) in conjunction with universal frame (part number 1007.24f0) for lumbar spine surgery. the hip elements may have a negative effect on patients- venous backflow under certain conditions and may have been a contributing factor to thromboembolic events.
  • Acción
    MAQUET sent an "Urgent Product Recall Medical Device Removal" notice and "Medical Device Removal Response Form" dated August 17, 2015 via UPS to affected customers. The notification identified the issue and the affected product. The notification instructed customers to read the notification and disseminate the information provided to all the users of the device; examine their inventory to determine if they have the Adjustable Positioning Elements; if so, remove the affected products, quarantine them and keep them in a secure location for shipment back to Maquet; and fill out and sign the accompany response form and send via email or fax to Maquet. If the customers have any questions regarding this field action, they were instructed to please contact their local MAQUET Representative or call MAQUET Customer Service at 1-888-627-8383 (Press option 2, then followed by option 3) Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. EDT.

Device

Maquet Universal Frame for Positioning Patients
  • Modelo / Serial
    Part Nos 1007.28A0 (Adjustable Positioning Elements and 1007.24F0 (Universal Frame with Adjustable Positioning Elements)
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including AL, CA, MO and Internationally to Australia, Brazil, Canada, China, Croatia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Russia, Singapore, South Africa and United Arab Emirates.
  • Descripción del producto
    Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer: Maquet GmbH, Germany || The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and after surgical interventions as well as for examination and treatment. With a patient in the prone position, the adjustable positioning elements stabilize the upper body while simultaneously relieving the abdominal region in the vertical position with regard to the spine and the large blood vessels there. This positioning method is thus suitable for interventions on the spine with dorsal access to prevent positioning-specific compression with resulting bleeding tenancies. They are made up of the following components: (2) chest and (2) hip elements with padding which are secured in a fixed arrangement to the frames and can be adjusted in all directions independently of each other.
  • Manufacturer
    Maquet Cardiovascular Us Sales, Llc

Manufacturer

Maquet Cardiovascular Us Sales, Llc
  • Dirección del fabricante
    Maquet Cardiovascular Us Sales, Llc, 45 Barbour Pond Drive, Wayne NJ 07470
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA