Events

Philips IntelliVue Patient Monitors ECG 12-lead option #C12(with the combination of s/w version (J.0, J.1, K.2, L.0) and ECG Firmware revision E.01.22) 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-2017-RN-01171-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-09-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01171-1
  • 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
    Philips has identified that st-segments in a 12-lead ecg may become distorted and the st-value may be inaccurate when an affected monitor automatically activates ecg filtering in the event that a “ecg check cable” or “ecg noisy elec xx” inop condition is triggered and displayed. these inops are triggered when the monitor detects a low impedance between ecg lead wires and the cable shield in the lead set, which can be caused by mechanical damage or fluid ingress.Distortions on the st-segment and associated numerics can contribute to a misdiagnosis or misinterpretation, which can cause a delayed or an incorrect treatment.
  • 조치
    Users are to complete and return the supplied acknowledgment form. Until the software is updated, users are to ensure that the “ECG Check Cable” or “ECG Noisy Elec xx” INOP is actioned following the instructions in the corresponding IFU. A Philips Healthcare representative will contact customers with affected devices to arrange a software update to correct the issue.

Device

Philips IntelliVue Patient Monitors ECG 12-lead option #C12(with the combination of s/w version (...
  • 모델명 / 제조번호(시리얼번호)
    Philips IntelliVue Patient Monitors ECG 12-lead option #C12(with the combination of s/w version (J.0, J.1, K.2, L.0) and ECG Firmware revision E.01.22)Affected Products:IntelliVue Multi Measurement ServerProduct Number: M3001AIntelliVue Multi Measurement Server SLCPProduct Number: M3001ALIntelliVue Multi Measurement Server X2Product Number: M3002AIntelliVue MP2Product Number: M8102AIntelliVue MP5Product Number: M8105AARTG Numbers: 118076 and 213953
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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