Events

Alerte De Sécurité sur GlideScope Reusable GVL, AVL, and Ranger 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.

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
    2013-05-27
  • Date de publication de l'événement
    2013-05-27
  • 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_20130527a.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 reusable gvl, avl, and ranger blades medical device manufacturer, verathon, has issued a field safety notice concerning all serial numbers of glidescope reusable gvl, avl, and ranger blades. this safety alert applies to all models of glidescope reusable blades currently in the field: reusable gvl 2 0574-0010, gvl 3 0574-0007, gvl 4 0574-0001, and gvl 5 0574-0030; avl reusable 2 0574-0118, avl reusable 3 0574-0115, avl reusable 4 0574-0116, and avl reusable 5 0574-0117; and ranger gvl 3 0574-0029, ranger gvl 4 0574-0028, and ranger gvl 4 with 2 foot cable 0574-0018. it does not apply to single use systems, including video batons and stats. the manufacturer has become aware that glidescope video laryngoscope customers continue to use reusable laryngoscope blades even when the blades show signs of serious wear and tear. the statement instructing users to inspect and monitor the product is currently located in the middle of the user’s manual under general maintenance information. this statement may not be sufficiently prominent to ensure that users do, in fact, inspect blades for wear and tear. therefore, verathon initiated a voluntary correction to strengthen the product labeling for all glidescope reusable blade. the manufacturer is highlighting the following warning statement in the user guide: "to ensure patient safety, routinely inspect the glidescope video laryngoscope blade before and after every use to ensure the blade is free of rough surfaces, sharp edges, cracks, protrusions, or any other indication of wear. if found, do not use the damaged or worn blade, otherwise blade breakage may occur which could cause patient injury or death. always ensure that alternative airway management methods and equipment are readily available." if you are in possession of the products, please contact your supplier for necessary actions. posted on 27 may 2013.

Device

GlideScope Reusable GVL, AVL, and Ranger Blades
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Verathon GlideScope Reusable GVL, AVL, and Ranger Blades
  • Manufacturer
    Verathon

Manufacturer

Verathon