Events

Siemens Z6Ms transesophageal transducer 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 Siemens Medical Solutions USA, Inc. 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
  • 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
    We have received reports about "acquisition errors" and the deterioration of material covering the articulating section of the z6ms transesophageal transducer. to date, no patient injury has been reported, and we believe the risk of injury to be remote. however, "acquisition errors" can cause a delay in the study for patients who are consciously sedated and possibly expose the patient to a second intubation. also, a compromise or fault in the transducer s material, combined with a failure to use a transducer sheath as directed in the user manual, may cause esophageal cuts, bleeding, and perforation to the patient, and severe trauma, electrical burns, and serious electrical hazards to the patient. .

Device

Siemens Z6Ms transesophageal transducer
  • 모델명 / 제조번호(시리얼번호)
    63029009 63029015 63029016 63229003 63229007 63229008 63229011 63229012 63230002 63230003 63230009 63260584 63260585 63319012 63322007 63325007 63328003 63328007 63329017 63329018 63332002 63332004 63360611 63360612 63430519 63430524 63432007 63432010 63432015 63432017 63530515 63530516 63530518
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.