Events

Lithium Ion Batteries, M4605A and M4607A for use with IntelliVue Patient Monitors 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-2014-RN-00514-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-05-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00514-1
  • 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
    On-going monitoring of quality data by the manufacturer has determined that the risk of battery failure increases with age, when a battery remains in use longer than 3 years after the date of manufacture or 500 charge-discharge cycles. such failure may result in overheating. battery management and safety practices information for the batteries m4605a / m4607a are not clearly documented in the instructions for use for intellivue patient monitors with software releases up to and including g.0. overheating of the battery may cause the battery to ignite or explode, which may result in injury to a patient or user.
  • 조치
    Philips is initiating this correction to provide an Addendum to the Instructions for Use for IntelliVue Patient Monitors with software releases up to and including G.0. The addendum describes that batteries M4605A / M4607A should be replaced after 3 years of continuous use after date of manufacture or 500 battery charge-discharge cycles. The addendum to the IntelliVue Patient Monitor IFU is included with the customer letter. This action has been closed-out on 10/02/2016.

Device

Lithium Ion Batteries, M4605A and M4607A for use with IntelliVue Patient Monitors
  • 모델명 / 제조번호(시리얼번호)
    Lithium Ion Batteries, M4605A and M4607A for use with IntelliVue Patient MonitorsModel numbers of the affected patient monitors :MP2, X2, MP5, MP20, MP30, MP40, MP50Product numbers: M3002A, M8102A, M8105A, M8105AT, M8001A, M8002A, M8003A, M8004AARTG Number: 94238
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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