Events

Verathon GlideScope GVL and AVL Reusable Video Laryngoscope BladesGVL 3 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Verathon Medical Australia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2015-RN-00461-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-06-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00461-1
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    Verathon, manufacturer of glidescope video laryngoscopes, is revising the operations and maintenance manuals (omm) for certain glidescope gvl and avl reusable laryngoscope blades. the new omms specifically state compatibility limitations of the reusable video laryngoscope validated through simulated use cycles, using certain cleaning and disinfection agents. also, for the purpose of cleaning/disinfecting reusable blades, the following chemicals have been removed from the omms:• bleach (sodium hypochlorite)• isopropyl alcohol solution• liquid hydrogen peroxide (7.5%)there is no change to the safety information provided in the omm regarding inspection of the laryngoscope blade before and after every use to ensure patient safety.
  • 조치
    Verathon is informing users regarding updates to the following Operations and Maintenance Manuals: • GVL Operations and Maintenance Manual: 0900-1204-08-60 • AVL Operations and Maintenance Manual: 0900-4200-02-60 The updated Operations and Maintenance Manuals can be found at www.verathon.com. This action has been closed-out on 11/08/2016.

Device

Verathon GlideScope GVL and AVL Reusable Video Laryngoscope BladesGVL 3
  • 모델명 / 제조번호(시리얼번호)
    Verathon GlideScope GVL and AVL Reusable Video Laryngoscope BladesGVL 3Part Number( PN): 0574-0007Serial Number Range(SN) : MD131860 - MD151622GVL 4PN: 0574-0001SN: LG131995 - LG151773GVL 5PN: 0574-0030SN: XL131578 - XL151524AVL 20574-0118AC131852 - AC151510AVL 30574-0115AD131589 - AD151506AVL 40574-0116AE131587 - AE151558AVL 50574-0117AF131504 - AF151500ARTG Number: 235136
  • Manufacturer
    Verathon Medical Australia Pty Ltd

Manufacturer

Verathon Medical Australia Pty Ltd