Events

IntelliSpace Critical Care & Anaesthesia Information Systems 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-2015-RN-00097-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-02-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00097-1
  • 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
    A software configuration defect has been identified that impacts one standard content (configuration that is shipped with the product) unit of measure (gm/m2) for the body surface area (bsa). the defect involves an incorrect multiplier in the configuration that causes an incorrect calculation of medication dosage. if the user does not identify that an incorrect multiplier exists in the standard content, a patient may receive a dose of medication that is incorrect (10 times the intended dosage).
  • 조치
    Users are advised to implement the instructions in the customer letter if the BSA (gm/m2) Standard Content is used in their systems configuration. Philips has initiated a software correction to address this issue. A Philips representative will contact customers to schedule the implementation of this correction. This action has been closed-out on 20/07/2016.

Device

IntelliSpace Critical Care & Anaesthesia Information Systems
  • 모델명 / 제조번호(시리얼번호)
    IntelliSpace Critical Care & Anaesthesia Information SystemsAffected Models:865047 IntelliVue Clinical Information Portfolio (ICIP), Rev D865209 IntelliVue Clinical Information Portfolio (ICIP), Rev E866072 IntelliSpace Critical Care & Anaesthesia (ICCA), Rev. F866148 IntelliSpace Critical Care & Anaesthesia (ICCA), Rev. GARTG Number: 98511
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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