Events

Carestation 600 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 GE Healthcare 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
    2016-02-10
  • 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
    The bvt switch may be difficult to move between the operating modes of the mechanical ventilation and the hand bag or it remains in the position and the patient can not be overcome by an anesthetic system. this problem can lead to loss of patient overflow and leads to hypoxia. so far, there have been no reports of injuries or complaints resulting from this problem. if the above problem occurs and no mechanical or manual ventilation mode can be used, a backup method is required for the patient's breathing. if problems with patient overflow occur, use a self-inflating bag immediately. before using the instructions, both in the user manual of the device and in the system's unsupervised system, include instructions on how to check whether the spare spraying, regardless of an anesthetic device, is available and working.

Device

Carestation 600
  • 모델명 / 제조번호(시리얼번호)
    Carestation 620 A1 (GTIN: 00840682103985): SM615020004WA to SM616010008WA; Carestation 650 A1 (GTIN: 00840682103947): SM715020005WA to SM716010008WA; Carestation 650c A1 (GTIN: 00840682103954): SM815020001WA to SM815500001WA.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare