Events

Cuff Controller with Clamp (monitors the cuff pressure of tracheal tubes for intubated patients) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Bosco Medical Australia 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-00429-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-04-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00429-1
  • 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 manufacturer has identified two issues relating to the power supply;- that the two halves of the power supply may come apart. if the two halves are not properly closed, there is a low risk of injury by electricity. as the conductive parts are secured by a fuse, severe injury is prevented. - the screw on domes for the housing of the power supply may break, and as a result, the housing itself may partially or completely come apart due to carious factors.It cannot be ruled out that the two issues may coincide and there is a low risk of injury by electricity.This action was undertaken prior to consultation with the therapeutic goods administration (tga).
  • 조치
    Bosco has advised users to inspect power supply units for any defects. Any affected devices should be returned to Bosco for replacement with unaffected units. This action has been closed-out on 17/08/2016.

Device

Cuff Controller with Clamp (monitors the cuff pressure of tracheal tubes for intubated patients)
  • 모델명 / 제조번호(시리얼번호)
    Cuff Controller with Clamp (monitors the cuff pressure of tracheal tubes for intubated patients)Model Number: 55-12-500Serial Numbers: 1506-CC02-0039, 1506-CC02-0040ARTG Number: 118226
  • Manufacturer
    Bosco Medical Australia

Manufacturer

Bosco Medical Australia