Events

Rappel de GlideScope Video Laryngoscope Reusable Blades (GVL, AVL)

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Verathon, Inc..

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
    71008
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0811-2016
  • Date de mise en oeuvre de l'événement
    2015-04-13
  • Date de publication de l'événement
    2015-07-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-10-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135841
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Laryngoscope, rigid - Product Code CCW
  • Cause
    Verathon has revised the operations and maintenance manual (omm) to specifically state compatibility limitations of the reusable video laryngoscope blade validated through simulated use cycles, such that exceeding this number of cycles in the specific chemical agent may affect the potential life of the product.
  • Action
    Verathon sent an Urgent Medical Device Safety Alert letter dated April 13, 2015 and Safety Alert Reply Form to their consignees on April 17, 2015 Users are informed that Verathon implemented a Safety Alert regarding updates to the following Operations and Maintenance Manuals (OMM): " GVL Operations and Maintenance Manual: 0900-1204-08-60 " AVL Operations and Maintenance Manual: 0900-4200-02-60 For a copy of the most recent GVL or AVL Operations and Maintenance Manual, please visit http://verathon.com/support. If you have any questions regarding the Operations and Maintenance Manuals revisions noted above, please contact your Verathon representative or Verathon Customer Care at 800.331.2313 or 425.867.1348. You may also email customerservice@verathon.com. PLEASE NOTE: NO ADDITIONAL ACTIONS NEED TO BE TAKEN.

Device

GlideScope Video Laryngoscope Reusable Blades (GVL, AVL)
  • Modèle / numéro de série
    Affected GVL Reusable Blades Serial Numbers, by Part Number  GVL 3- 0574-0007: MD131859- MD151622; GVL 4- 0574-0001: LG131994- LG151773; GVL 5- 0574-0030: XL131577- XL151524.  Affected AVL Reusable Blades Serial Numbers, by Part Numbers:  AVL 2- 0574-0118: AC131852- AC151510; AVL 3- 0574-0115: AD131589- AD151506;  AVL 4- 0574-0116: AE131586- AE151558; AVL 5- 0574-0117: AF131503- AF151500.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5). || GVL: The GlideScope Video Laryngoscope is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor. || AVL: The GlideScope AVL Video Monitor system has the same intended use as the GVL System. The difference between systems is that the AVL has a digital platform and the GVL an analog platform.
  • Manufacturer
    Verathon, Inc.

Manufacturer

Verathon, Inc.
  • Adresse du fabricant
    Verathon, Inc., 20001 N Creek Pkwy, Bothell WA 98011-8218
  • Société-mère du fabricant (2017)
    Roper Technologies Inc
  • Source
    USFDA