VersaCare Bed 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Hill-Rom 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
    2012-08-29
  • 사례 출판 날짜
    2012-08-29
  • 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: hill-rom versacare bed medical device manufacturer, hill-rom, has issued a medical device safety alert concerning versacare bed (revision e through j, serial number h345ad5880 through n138al9061). according to the manufacturer, hill-rom versacare bed has a built-in safety feature intended to protect the patient under certain conditions where bed movement could cause harm. this functional lockout feature is designed to disable the bed. however, the manufacturer has received complaints that the lockout is occurring on the bed of the captioned model when it should not. after an extensive review of this issue, the manufacturer has determined that the majority of these lockouts are related to technical problem on the printed circuit (pc) board within each versacare bed siderail. the manufacturer has identified the root cause to an intermittent connection between a chip and socket on the pc board. the manufacturer will provide a correction for the chip/socket problem which involves replacement of the pc boards in both head-end siderails. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 29 august 2012.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Hill-Rom VersaCare Bed
  • Manufacturer

Manufacturer