Events

Single-width Airway Module E-miniC and Extension Modules N-FC & N-FCREC (used with CARESCAPE Monitors B850, B650 and B450, S/5 modular monitors, Engstrom Carestation, Patient Monitor B30, S/5M and FML monitors) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 GE Healthcare Australia 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-2014-RN-00543-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-05-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00543-1
  • 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
    Ge healthcare has become aware of a potential safety issue due to failure of the carbon dioxide detector associated with single-width airway and extension modules. failure of the carbon dioxide detector in single-width airway and extension modules may cause a slow continuous decrease of measured et-/fico2 values. incorrect et co2/fi co2 value may impair clinical decision making for both mechanically and spontaneously ventilated patients because of incorrect low co2 values.
  • 조치
    GE is providing calibration instructions to assist their customers to determine if their module is affected. If the carbon dioxide reading is out of range after the first successful calibration procedure end users are advised to discontinue use and contact a GE service representative. GE will arrange with customers for a correction to ensure this issue does not occur. This action has been closed-out on 02/02/2016.

Device

Single-width Airway Module E-miniC and Extension Modules N-FC & N-FCREC (used with CARESCAPE Moni...
  • 모델명 / 제조번호(시리얼번호)
    Single-width Airway Module E-miniC and Extension Modules N-FC & N-FCREC (used with CARESCAPE Monitors B850, B650 and B450, S/5 modular monitors, Engstrom Carestation, Patient Monitor B30, S/5M and FML monitors)Single-width Airway Module E-miniCSerial Numbers: 6818561 to 6898777Extension Modules N-FC & N-FCRECSerial Numbers: 6799191 to 6905206ARTG Number: 166230
  • 의료기기 분류등급
    Anesthesiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd