Events

Contoura 450 and Project Versions of 25000E/L Hospital Bed Frames 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 ArjoHuntleigh 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
    2013-11-26
  • 사례 출판 날짜
    2013-11-26
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131126.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: arjohuntleigh contoura 450 and project versions of 25000e/l hospital bed frames the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a medical device safety alert concerning contoura 450 and project versions of 25000e/l hospital bed frames manufactured by arjohuntleigh. model numbers c450l, 25000e/lpd73, 25000e/lpd77, 25000e/lpd75, 25000e/lpd76, 25000e/lpd90 and 25000e/lpe12 are affected. spare backrest actuators (part number s6686, linak ref. 321021) for the bed frames indicated above are supplied with a pre-wired safety limit switch (sls) that operates as the actuator extends and prevents the backrest being driven to angles greater than 60o above the horizontal. according to the manufacturer, approximately 200 of these actuators sold as spare parts were supplied with the sls incorrectly connected. on beds fitted with these parts, if the backrest is driven to an angle of 60o, the sls does not operate as intended and the backrest continues to rise until the actuator reaches its limit of travel. once in this position, it may not be possible to lower the backrest, either electrically or by using the manual cardiopulmonary resuscitation (cpr) release. it is potentially life-threatening if the backrest cannot be lowered when a patient requires cpr or other emergency treatment. arjohuntleigh advises the users to test all suspect actuators according to the instructions given in the field safety notice. faulty actuators should be returned to arjohuntleigh for modification or disposal. according to the local supplier, the affected products were not distributed in hong kong. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con336744 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 26 november 2013.

Device

Contoura 450 and Project Versions of 25000E/L Hospital Bed Frames
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: ArjoHuntleigh Contoura 450 and Project Versions of 25000E/L Hospital Bed Frames
  • Manufacturer
    ArjoHuntleigh

Manufacturer

ArjoHuntleigh