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.
데이터 추가 비고
Laryngoscope, rigid - Product Code CCW
원인
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.
조치
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.
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.