Events

StimPod NMS 450 Nerve Stimulator 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Xavant Technology 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
    16612
  • 사례 시작날짜
    2014-05-02
  • 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: Anatech Medical Ltd, P O Box 0171, 9 Pirihi Road, Takahiwai, Ruakaka, Whangarei
  • 원인
    In isolated incidences (less than 0.003%) 0 while using the device in nmba monitoring mode, electrodes used may deteriorate to a level where current densities may be large enough to cause superficial burns on the skin of the patient. the occurrence of this phenomena is due to a lack of training on the impedance monitoring fucntion of the device and it is imperative that users are properly trained to monitor the impedance of the electrode/skin impedance through the actual current delivered function in mnba with all stmpof nms450s.
  • 조치
    Instructions for use to be updated

Device

StimPod NMS 450 Nerve Stimulator
  • 모델명 / 제조번호(시리얼번호)
    Model: XT-45011, XT-45011-NA, XT-45001 and XT-45001-NA, Affected:
  • Manufacturer
    Xavant Technology

Manufacturer

Xavant Technology