IW900-series Infant Warmers 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Fisher & Paykel Healthcare 에 의해 제조된 제품과 관련되어 있습니다.

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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
    2014-11-06
  • 사례 출판 날짜
    2014-11-06
  • 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: fisher & paykel healthcare iw900-series infant warmers it has come to our attention that medical device manufacturer, fisher & paykel healthcare, has initiated a field safety corrective action concerning some of its iw900-series infant warmers. there were two confirmed reports of breakage of the nut that secures the heater head in place. breakage of the nut can cause the heater head to become partially detached and swing towards the bassinet. the heater head did not contact the patient in either case, however there is the potential that a heater head could contact a patient situated on the bassinet and cause a serious injury. users should check whether they have the affected infant warmers and the spare parts. the manufacturer is supplying replacement pivot securing nuts to all affected customers. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 november 2014.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Fisher & Paykel Healthcare IW900-series Infant Warmers
  • Manufacturer

Manufacturer