Events

PARI SOLE N Inhalation Device 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 FRIWO 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
    2012-09-11
  • 사례 출판 날짜
    2012-09-11
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120911c.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: power adapter used in pari sole n inhalation device the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning the power adapter manufactured by friwo used in pari sole n inhalation device. pari gmbh has received a small number of complaints regarding the mains adapter manufactured by friwo that is used with the pari sole n inhalation device. the complaints received concerned the mains adapter overheating and causing a certain part of the power adapter housing to melt. it may pose the risk of electric shock or fire. none of the reported incidents led to any personal injury or damage due to fire. the manufacturer advised users to inspect the power adapter before each use to ensure that it is not damaged. the device must not be switched on if damaged or damage is suspected. users should contact the manufacturer for replacement of the power adapter. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/ safetywarningsalertsandrecalls/fieldsafetynotices/con184398 if you are in possession of the product, please contact your supplier for necessary actions. posted on 11 september 2012.

Device

PARI SOLE N Inhalation Device
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Power Adapter used in PARI SOLE N Inhalation Device
  • Manufacturer
    FRIWO

Manufacturer

FRIWO