Events

Rappel de Glidescope Titanium Single-Use Video Laryngoscope Blades Product: LoPro S3, LoPro S4, MAC S3 & MAC S4 Single Blade and Box of 10

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Verathon Medical Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2016-RN-00133-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-02-04
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00133-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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...
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Anesthesiology Devices
  • Manufacturer
    Verathon Medical Australia Pty Ltd

Manufacturer

Verathon Medical Australia Pty Ltd