Events

unkown device 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Hill Rom Inc 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
  • 사례 ID
    I1409-367
  • 사례 연번
    2013DM -0010757
  • 날짜
    2014-09-08
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=196
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer issues certain recommendations to avoid the deterioration of the coupling systems of the foot section of the device produced by subjecting them to constant knocks and falls, leading to possible possible adverse events on patients or users.

Device

unkown device
  • 모델명 / 제조번호(시리얼번호)
    AFFINITY models P3700B, P3700C, P3700D and P3700E, manufactured between October 2006 and June 2014.
  • 제품 설명
    AFFINITY ™ FOUR obstetric beds are intended to be used as delivery cares for pregnant women with LDR (dilatation, delivery and recovery) or LDRP (dilation, delivery, recovery and postpartum). The hospital systems VERSACA RE ™ and TOTA LCA RE ™ s systems offer patient support perfectly adapted to hospital environments. Care units and intensive surveillance, medical-surgical care, post-anesthesia care unit and deurgery rooms, among others, can be used. The P ROGRESSA ™ bed is designed for the prevention or treatment of pulmonary complications or other associated complications with immobility; for the treatment or prevention of pressure ulcers; or for any other purpose where medical benefits can be obtained from continuous lateral rotation therapy or dermal / percussion therapy.
  • Manufacturer
    Hill Rom Inc

Manufacturer

Hill Rom Inc