Events

WATO EX-65 and A-Series (A5/A7) anaesthesia machines 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Mindray 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-2017-RN-01066-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-08-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01066-1
  • 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
    Mindray has identified a potential issue related to electrically erasable programmable read-only memory (eeprom) which will only occur if the system’s total number of write cycles to a particular range of memory locations has exceeded the life specification of the eeprom. the issue will only manifest at start up or at the end of a case; it will not occur during a case. there are no adverse effects on the patient.To date, there have been no reports of injuries associated with this issue.
  • 조치
    The manufacturer recommeds cessation of the use of machines which have experienced this fault. Units which have not experienced the fault may be used as normal. A software upgrade is planned.

Device

WATO EX-65 and A-Series (A5/A7) anaesthesia machines
  • 모델명 / 제조번호(시리얼번호)
    WATO EX-65 and A-Series (A5/A7) anaesthesia machinesMultiple Serial NumbersARTG Number: 158607
  • Manufacturer
    Mindray Medical Australia Pty Ltd

Manufacturer

Mindray Medical Australia Pty Ltd