Events

PATIENT DATA MODULE 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE) 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
    58986
  • 사례 위험등급
    II
  • 사례 시작날짜
    2014-08-27
  • 사례 국가
    Canada
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    The following issue is being addressed by ge healthcare file no. fmi 36107: if the pdm is quickly disconnected and reconnected (a less than 10 second cycle) from a carescape bx50 monitor following a "patient discharge" or during active monitoring the ecg waveform and its associated waveform parameters could be analyzed incorrectly. the ecg heart rate (hr) parameter data the ecg waveform analysis and other ecg parameter measurements are displayed at values that will be less than the actual patient's physiologic condition. as a result of the abnormal analysis of data the alarms for serious conditions may not be triggered appropriately. the issue potentially affects heart rate ecg st segment analysis 12 lead ecg analysis ecg spo2 respiration and invasive blood pressure waveforms both locally and at cic and data displayed at cic may show data drop out. neither bedside nor cic data can reliably represent the parameters being measured. if your facility uses the pdm only with transport pro or solar monitors the issue does not exist.

Device

PATIENT DATA MODULE

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)