Panorama Central Station, software versions 10.0 to 11.3 and patient Monitoring Network 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Ulco Engineering 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-2014-RN-01158-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-10-30
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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 an issue related to the panorama central station where full disclosure data (includes patient data, waveforms, and events) may lag behind the panorama system time clock when the panorama central station is in use with mindray’s v-series monitor. the full disclosure data may be a minimum of 6 seconds behind the panorama system time clock and may grow at a rate of 5 to 7 seconds per day if the v-series monitor remains connected to the panorama central station without interruption. this issue may also lead to the inability to print the most recent “full disclosure” data if the lag time exceeds 21 seconds. if the lag time exceeds 30 seconds, non-invasive blood pressure measurement contained in the “list trends” may appear out of time order. there are no reports of injuries associated with these issues.
  • 조치
    Mindray is arranging software upgrade to eliminate this issue. Customers are advised that a break in communications, admitting or discharging a patient or putting the V-Series in standby will, temporarily, eliminate the issue. This action has been closed-out on 26/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    Panorama Central Station, software versions 10.0 to 11.3 and patient Monitoring NetworkSerial Number: RM01940-F2ARTG Numbers: 223386
  • Manufacturer

Manufacturer