Events

Philips IntelliVue Patient Monitor, lithium ion battery 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Childrens Medical Ventures 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
    16675
  • 사례 시작날짜
    2014-05-09
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • 원인
    On-going monitoring of quality data 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.
  • 조치
    Instructions for use to be updated

Device

Philips IntelliVue Patient Monitor, lithium ion battery
  • 모델명 / 제조번호(시리얼번호)
    Model: Battery models: M4605A and M4607A, Affected: All batteries
  • Manufacturer
    Childrens Medical Ventures

Manufacturer

Childrens Medical Ventures
  • 제조사 모회사 (2017)
    Philips
  • Source
    NZMMDSA