Events

Retiro De Equipo (Recall) de Verathon GlideScope GVL and AVL Reusable Video Laryngoscope BladesGVL 3

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Verathon Medical Australia Pty Ltd.

¿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
    RC-2015-RN-00461-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-03
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00461-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Verathon, manufacturer of glidescope video laryngoscopes, is revising the operations and maintenance manuals (omm) for certain glidescope gvl and avl reusable laryngoscope blades. the new omms specifically state compatibility limitations of the reusable video laryngoscope validated through simulated use cycles, using certain cleaning and disinfection agents. also, for the purpose of cleaning/disinfecting reusable blades, the following chemicals have been removed from the omms:• bleach (sodium hypochlorite)• isopropyl alcohol solution• liquid hydrogen peroxide (7.5%)there is no change to the safety information provided in the omm regarding inspection of the laryngoscope blade before and after every use to ensure patient safety.
  • Acción
    Verathon is informing users regarding updates to the following Operations and Maintenance Manuals: • GVL Operations and Maintenance Manual: 0900-1204-08-60 • AVL Operations and Maintenance Manual: 0900-4200-02-60 The updated Operations and Maintenance Manuals can be found at www.verathon.com. This action has been closed-out on 11/08/2016.

Device

Verathon GlideScope GVL and AVL Reusable Video Laryngoscope BladesGVL 3
  • Modelo / Serial
    Verathon GlideScope GVL and AVL Reusable Video Laryngoscope BladesGVL 3Part Number( PN): 0574-0007Serial Number Range(SN) : MD131860 - MD151622GVL 4PN: 0574-0001SN: LG131995 - LG151773GVL 5PN: 0574-0030SN: XL131578 - XL151524AVL 20574-0118AC131852 - AC151510AVL 30574-0115AD131589 - AD151506AVL 40574-0116AE131587 - AE151558AVL 50574-0117AF131504 - AF151500ARTG Number: 235136
  • Manufacturer
    Verathon Medical Australia Pty Ltd

Manufacturer

Verathon Medical Australia Pty Ltd