Events

Retiro De Equipo (Recall) de Glidescope Titanium Single-Use Video Laryngoscope Blades Product: LoPro S3, LoPro S4, MAC S3 & MAC S4 Single Blade and Box of 10

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-2016-RN-00133-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-02-04
  • 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-2016-RN-00133-1
  • 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
    The affected glidescope (gs) titanium (ti) single use (su) video laryngoscope blades may cause significant disruption (flickering) in the video laryngoscopy image during an intubation procedure.If a glidescope titanium su blade causes image flickering during an intubation procedure, there may be a short delay while the physician completes the intubation with a disrupted video image. if flickering is so severe that the video image cannot be relied upon to complete the intubation, then the failure of the intubation procedure, and accompanying delay while a different su blade or laryngoscope is located, could result in patient death or serious injury. at this time, verathon is not aware of any instances of patient injuries or deaths attributed to this potential failure.
  • Acción
    Verathon is advising users to inspect stock and quarantine the affected units prior to their return. Verathon will replace the affected units. This action has been closed-out on 09/05/2017.

Device

Glidescope Titanium Single-Use Video Laryngoscope Blades Product: LoPro S3, LoPro S4, MAC S3 & MA...
  • Modelo / Serial
    Glidescope Titanium Single-Use Video Laryngoscope BladesProduct: LoPro S3, LoPro S4, MAC S3 & MAC S4Single Blade and Box of 10Multiple Model NumbersMultiple Lot NumbersARTG Number: 235136
  • Clasificación del producto
    Anesthesiology Devices
  • Manufacturer
    Verathon Medical Australia Pty Ltd

Manufacturer

Verathon Medical Australia Pty Ltd