Events

G5/HAMILTON-S1 ventilators 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 Hamilton Medical AG 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
    2016-03-07
  • 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
    Investigations have shown that after performing the suctioning maneuver, including disconnecting the patient, suctioning, and reconnecting the patient, the preset pattern of ventilation may not continue as expected. under certain conditions, a different ventilation mode than the operator- selected mode may be applied; this situation can occur independent from the selected patient group (neonate, pediatric, or adult). this situation may occur in the hamilton-g5 and hamilton-s1 if the ventilation mode changes during the pre-oxygenation phase. after the suctioning maneuver is finished and the patient is reconnected, the ventilation mode active before the pre-oxygenation phase is used. under these conditions, the ventilation mode displayed by the ventilator is not the same as the applied ventilation mode. .

Device

G5/HAMILTON-S1 ventilators
  • 모델명 / 제조번호(시리얼번호)
    All HAMILTON-G5/HAMILTON-S1 ventilators with software versions v2.41, v2.42 and v2.50
  • Manufacturer
    Hamilton Medical AG

Manufacturer

Hamilton Medical AG