Events

Maquet/Datascope CS100i Intra-Aortic Balloon Pump (IABP) Maquet/Datascope CS100 Intra-Aortic Balloon Pump (IABP) Maquet/Datascope CS300 Intra-Aortic Balloon Pump (IABP) 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 Getinge 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 날짜
    2017-07-17
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • 데이터 추가 비고
  • 원인
    Maquet/getinge has received complaints involving the cs100/cs100i and cs300 iabps regarding the following issues: • false blood detection alarm, and • the ingress of fluids into the iabp affecting various electronic circuit boards. either issue could potentially prevent initiation or continuation of therapy. this field corrective action addresses both issues. maquet/getinge would like to inform our customers affected by the field corrections that the risk-benefit of using an affected cs100/cs100i or cs300 iabp should be assessed by your medical team for each patient, when no alternative iabp or alternative therapy is available. .

Device

Maquet/Datascope CS100i Intra-Aortic Balloon Pump (IABP) Maquet/Datascope CS100 Intra-Aortic Bal...
  • 모델명 / 제조번호(시리얼번호)
    0998-UC-0446HXX; 0998-UC-0479HXX 0998-00-3013-XX; 0998-UC-3013-XX 0998-00-3023-XX; 0998-UC-3023-XX
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Getinge

Manufacturer

Getinge