Events

ABP Monitor, Model 90217A 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Spacelabs 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
    2011-11-15
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111115a.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
    Mhra fsn safety alert: spacelabs healthcare abp monitor, model 90217a the medicines and healthcare products regulatory agencies (mhra), united kingdom has issued a field safety notice on ambulatory blood pressure monitor, model 90217a, manufactured by spacelabs healthcare. the manufacturer has identified a potential error code associated with the use of the product. if external pressure is applied to the cuff during deflation, the monitor will cease to function and display an ec75 error code. according to the manufacturer, there have been no injuries associated with this issue. spacelabs healthcare suggests the users to cycle the power off if error code is observed. the manufacturer is in the progress of upgrading the software. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

ABP Monitor, Model 90217A
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Spacelabs Healthcare ABP Monitor, Model 90217A
  • Manufacturer
    Spacelabs Healthcare

Manufacturer

Spacelabs Healthcare