Events

Glidescope Titanium Single-Use Video Laryngoscope Blades Product: LoPro S3, LoPro S4, MAC S3 & MAC S4 Single Blade and Box of 10 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-2016-RN-00133-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-02-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00133-1
  • 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
    The affected glidescope (gs) titanium (ti) single use (su) video laryngoscope blades may cause significant disruption (flickering) in the video laryngoscopy image during an intubation procedure.If a glidescope titanium su blade causes image flickering during an intubation procedure, there may be a short delay while the physician completes the intubation with a disrupted video image. if flickering is so severe that the video image cannot be relied upon to complete the intubation, then the failure of the intubation procedure, and accompanying delay while a different su blade or laryngoscope is located, could result in patient death or serious injury. at this time, verathon is not aware of any instances of patient injuries or deaths attributed to this potential failure.
  • 조치
    Verathon is advising users to inspect stock and quarantine the affected units prior to their return. Verathon will replace the affected units. This action has been closed-out on 09/05/2017.

Device

Glidescope Titanium Single-Use Video Laryngoscope Blades Product: LoPro S3, LoPro S4, MAC S3 & MA...
  • 모델명 / 제조번호(시리얼번호)
    Glidescope Titanium Single-Use Video Laryngoscope BladesProduct: LoPro S3, LoPro S4, MAC S3 & MAC S4Single Blade and Box of 10Multiple Model NumbersMultiple Lot NumbersARTG Number: 235136
  • 의료기기 분류등급
    Anesthesiology Devices
  • Manufacturer
    Verathon Medical Australia Pty Ltd

Manufacturer

Verathon Medical Australia Pty Ltd