Events

Dynamis and Gerialit with Dewert electrical control systems 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Hill-Rom 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert / Field Safety Notice
  • 사례 ID
    MDA/2013/031
  • 사례 연번
    CON272240
  • 날짜
    2013-05-10
  • 사례 출판 날짜
    2013-05-10
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON272240?tabName=allTabs
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • 데이터 추가 비고
  • 원인
    Risk of serious injury to patients, staff and visitors. unintentional movement, including sudden collapse to its lowest position, can occur when the bed is connected to the mains supply. a field safety notice (fsn) was published on 01 march 2012.  however, the manufacturer has since advised that these beds should be fixed to their lowest position and the control system deactivated to remove the risk of injury.
  • 조치
    Identify affected beds. Consider removing affected beds from use if alternatives are available. If an alternative is not available: consider whether continuing to use the beds at their fixed, lowest position is acceptable if acceptable, fix the beds to their lowest position and contact the manufacturer for instructions on how to deactivate the Dewert control system. Confirm with the manufacturer your actions when completed.

Device

Dynamis and Gerialit with Dewert electrical control systems
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Hospital beds: Dynamis and Gerialit with Dewert electrical control systems. Specific models numbers manufactured from October 1995 to June 2001 inclusive. Dynamis and Gérialit beds were manufactured with electrical control systems supplied by either Dewert or SKF. This notification applies only to Dewert systems, which are easily recognizable by the design of the lockout unit, as shown in the manufacturer’s Field Safety Notice, MOD 466. Affected model numbers: LI146B1—LI146BI, LI146D1—LI146DI, LI147B1—LI147D1, LI150A0—LI150B0, LI163B1—LI163C1, PRS0128, PRS0199, PRS0201, PRS2001.
  • Manufacturer
    Hill-Rom

Manufacturer

Hill-Rom