Events

PROCARE B20 and B40 Monitors 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 GE Healthcare 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
    2012-11-06
  • 사례 출판 날짜
    2012-11-06
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121106.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: ge procare b20 and b40 monitors the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning procare b20 and b40 monitors, manufactured by ge healthcare. according to the manufacturer, the ‘v tachy’ and ‘v fib’ alarms of monitor procare b20 or procare b40 are disabled in neonatal mode which could result in a missed lethal arrhythmia alarm and a potentially critical event. other modes and parameters are not affected. the issue affects monitor procare b20 or b40 devices with the software version vsp-a_1.10 (or earlier). the manufacturer advised clinician should stop using monitor in neonatal mode. they will provide a software solution to correct this issue. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con199544 if you are in possession of the product, please contact your supplier for necessary actions. posted on 6 november 2012.

Device

PROCARE B20 and B40 Monitors
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: GE PROCARE B20 and B40 Monitors
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare