Siemens Rechargeable Hearing Aids Charger 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Siemens 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
    2012-09-06
  • 사례 출판 날짜
    2012-09-06
  • 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: siemens rechargeable hearing aids charger it has come to our attention that medical device manufacturer, siemens has issued a field safety corrective action regarding the euro plug power supply used with chargers for rechargeable hearing aids with the following model numbers: gt-41076-0605 & gtm41076-0605. the manufacturer received 2 reports on a defect of the plug power supply used with chargers for rechargeable hearing aids. the affected component part is the euro plug adapter. in one case a person sustained an electrical shock. when pulling the power supply from the power socket, the plug contacts may separate from the housing and remain in the socket which poses a risk of electrical shock. this error is caused by incomplete ultrasound welding of the euro plug adapter component. if the plug contacts should separate from the power supply and remain in the power socket, the manufacturer provided the following advice to affected users: do not touch the contacts which are stuck in the power socket disconnect the power socket from the power grid and remove the separated plug contacts.Do not touch any bare metal parts during removal. if you are not sure, ask an electrician for assistance. take the damaged power supply to your acoustician. the manufacturer also advised affected users to contact their hearing aid acoustician within 2 weeks who will inspect the euro plug adapter. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 6 september 2012.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Siemens Rechargeable Hearing Aids Charger
  • Manufacturer

Manufacturer