P300 and C300 Ceiling Hoist 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Prism Medical 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
    2015-10-02
  • 사례 출판 날짜
    2015-10-02
  • 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: prism medical p300 and c300 ceiling hoist the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning p300 and c300 ceiling hoists, manufactured by prism medical. the affected model and serial numbers are shown below: lifter p300: models: 303050, 303051; serial: p303470 – 479, p304158/164/171/172, p304536 – 539, p304866/867, p305116/118, p305125 – 127, p305130/134/135 lifter c300: models: 330050, 330053; serial: c303221/224/225, cq303107 – 116 the manufacturer has been made aware of 17 incidents involving 300 series lifts in which the drive gear shaft has broken, eliminating the lifts ability to raise or lower a patient. of these 17 incidents, the manufacturer has discovered 3 in which the free fall protection system did not engage properly. if both of these incidents occur at the same time, there is a risk for the person being supported by the lift to drop unexpectedly. according to the safety alert, the patients involved in the 3 incidents were not seriously injured and did not require medical attention. for details, please refer to the tga website:http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-00967-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 october 2015.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Prism Medical P300 and C300 Ceiling Hoist
  • Manufacturer

Manufacturer

  • Source
    DH