Events

BeneHeart D1 Defibrillator/ Monitor 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Mindray 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2014-11-18
  • 사례 출판 날짜
    2014-11-18
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141118b.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: beneheart d1 defibrillator/ monitor the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning beneheart d1 defibrillator/ monitor, manufactured by mindray. the affected product is beneheart d1 with the first four digits of the serial number as fq37/ fq38/ fq39/ fq3a/ fq3b/ fq3c/ fq41/ fq42/ fq43/ fq44/ fq45/ fq46/ fq47. the manufacturer has identified the affected aeds might fail to boot. when this issue occurs, the status indicator of the aed is off. the reason for the startup failure of the aed is due to abnormal reset of the power management circuit on the main control board. the manufacturer advises affected users to discontinue use of the aed. the manufacturer will repair the affected aeds as soon as possible. for details, please refer to the following link: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con473632 according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 18 november 2014.

Device

BeneHeart D1 Defibrillator/ Monitor
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: BeneHeart D1 Defibrillator/ Monitor
  • Manufacturer
    Mindray

Manufacturer

Mindray