Events

Alerte De Sécurité sur GlideScope GVL Video Laryngoscope Reusable Blades

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Verathon Inc.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2012-12-03
  • Date de publication de l'événement
    2012-12-03
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121203.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: verathon glidescope gvl video laryngoscope reusable blades the united states food and drug administration (fda) posted a firm press release concerning glidescope gvl video laryngoscope reusable blades, manufactured by verathon inc. the manufacturer initiated a voluntary recall of glidescope gvl video laryngoscopes reusable blades that were manufactured between december 2010 and august 2011. the recall includes the following models within the specified serial number ranges: glidescope gvl 3, 0574-0007: md10500 to md112387; glidescope gvl 4, 0574-0001: lg105000 to lg112758 and glidescope gvl 5, 0574-0030: xl105000 to xl111798. the firm voluntarily recalled the products after learning about design characteristics leading to cracked and broken blades. these laryngoscope blades have been found to be prone to developing cracks and/or breaking across the tip of the blade, which potentially could result in pieces of the blade breaking off in patient’s mouths and obstructing the airway or being swallowed. the manufacturer suggests healthcare facilities that have glidescope gvl recalling reusable blades to stop using the blades and contact verathon customer care to obtain a replacement blade. for details, please refer to the following fda website: http://www.Fda.Gov/safety/recalls/ucm330305.Htm. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 3 december 2012.

Device

GlideScope GVL Video Laryngoscope Reusable Blades
  • Modèle / numéro de série
  • Classification du dispositif
    Anesthesiology Devices
  • Description du dispositif
    Medical Device Safety Alert: Verathon GlideScope GVL Video Laryngoscope Reusable Blades
  • Manufacturer
    Verathon Inc

Manufacturer

Verathon Inc