Events

Dräger Jaundice Meters 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Draeger 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-2018-RN-00325-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-04-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00325-1
  • 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
    Draeger has determined through post market surveillance activities that some users have concerns about the method used by the jm-103 and jm-105 to indicate that a taken measurement is out of range (higher than the measuring range of the device). uncertainty about high value indication may result in delayed treatment of a patient with hyperbilirubinemia.As described in the instructions for use manual and in the device's training materials:- jaundice meter model jm-103 displays a blinking "- - -" when the measurement is out of range. the measuring range is defined to 340 µmol/l; and - jaundice meter model jm-105 displays a blinking "- 0 -" when the measurement is out of range. the measuring range is defined to 340 µmol/l.
  • 조치
    Draeger is providing users with stickers to adhere to JM-103 and JM-105 devices to re-enforce the meaning of the associated blinking units "---" for JM-103 and "-0-" for JM-105 when the measurement is higher than the measuring range of the device. Users are to refer to the instructions provided on the Customer Letter for correct location for the stickers.

Device

Dräger Jaundice Meters
  • 모델명 / 제조번호(시리얼번호)
    Dräger Jaundice MetersModels Numbers: JM-103 and JM-105 ARTG Number: 152624Draeger Australia - Analyser, bilirubinometer
  • Manufacturer
    Draeger Australia Pty Ltd

Manufacturer

Draeger Australia Pty Ltd