Battery pack for MEDUCORE Easy 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 WEINMANN Emergency Medical Technology 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
    2017-02-21
  • 사례 출판 날짜
    2017-02-21
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 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: battery pack for meducore easy the medicines and healthcare products regulatory agency (mhra), united kingdom has posted a medical device safety alert concerning the battery pack for meducore easy, manufactured by weinmann emergency medical technology [model: wm 40155; serial number: below 20000]. the manufacturer has found that in very rare cases, the battery pack may fail. in the fault situation, it would no longer be possible to administer a shock to the patient. according to the manufacturer, the rechargeable battery pack for meducore easy (wm 40150) is not affected and can continue to be used without restriction. the users are advised to take the following actions: replace battery packs with serial numbers below 20000 with a new battery pack; ensure that they carry an alternative replacement device when on professional duty (emergency service) until they receive a replacement battery pack; and if the device displays the fault described above when they are on duty, continue first-aid measures in line with erc guideline 2015 product replacement is on-going. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notices-13-february-17-february-2017 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 february 2017.

Device