Events

Philips IntelliVue MX40 Patient Wearable Monitor s/w versions B.05.28, B.05.29 and B.05.32 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Philips Electronics Australia 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-01297-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-10-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01297-1
  • 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
    When the local "alarms on" configuration setting on the phillips intellivue mx40 patient wearable monitor is modified from its factory default, in certain software revisions, it will disable generation and delivery of ecg alarms to the philips intellivue information center ix (piic ix) without a visual indication on the piic ix that the ecg alarms have been disabled. if the generation and delivery of ecg alarms to the information center is disabled without a corresponding visual indication at the information center, a delay in treatment could occur.
  • 조치
    Phillips is implementing software upgrade for affected Phillips IntelliVue MX40 Patient Wearable Monitors. Users with affected devices will be contacted by a Phillips Healthcare representative for the installation of the software upgrade. In the interim, users are advised to make sure that the MX40 Patient Wearable Monitor local configuration setting ‘Alarms On’ is configured to its factory default. Philips is providing instructions to change the local configuration settings in the customer letter.

Device

Philips IntelliVue MX40 Patient Wearable Monitor s/w versions B.05.28, B.05.29 and B.05.32
  • 모델명 / 제조번호(시리얼번호)
    Philips IntelliVue MX40 Patient Wearable Monitor s/w versions B.05.28, B.05.29 and B.05.32Product Numbers: 865351, 865352 Exchange Part Numbers: 453564262531, 453564262551, 453564262571, 453564262591, 453564615351, 453564615371Product number and Exchange part number (identified as Service #) are displayed on the devices product label located on the back of the deviceARTG Number: 99204
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • 제조사 모회사 (2017)
    Philips
  • Source
    DHTGA