Events

Integra Camino Intracranial Pressure (ICP) Monitor and the Integra Licox PtO2 and Temperature MonitorIntegra Camino Intracranial Pressure (ICP) Monitor 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Integra Neurosciences Pty 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-2016-RN-00030-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-01-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00030-1
  • 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
    The speakers in camino icp monitors (cam02) and the licox pto2 and temperature monitors (lcx02) may potentially malfunction. if this occurs, the monitors will stop providing an audible tone at start-up or at alarm points during use. although unlikely, this may lead to central herniation that could potentially result in brain death or reversible ischemia; moderate hypoxic brain injury; elevation of icp or decrease in pto2. no reports of patient injury or adverse events have been received.
  • 조치
    The affected units are to be returned to the manufacturer for a software upgrade to lower the input signal supplied to the speaker assembly. The monitor case will also be modified to increase the decibel level.

Device

Integra Camino Intracranial Pressure (ICP) Monitor and the Integra Licox PtO2 and Temperature Mon...
  • 모델명 / 제조번호(시리얼번호)
    Integra Camino Intracranial Pressure (ICP) Monitor and the Integra Licox PtO2 and Temperature MonitorIntegra Camino Intracranial Pressure (ICP) MonitorCatalogue Number: CAM02 All serial numbers affectedIntegra Licox PtO2 and Temperature MonitorCatalogue Number: LCX02All serial numbers affectedARTG Number: 216915 and 217355
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd