Events

Pediatric Bed Structure Model E-1943 HARD 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 HARD Mfg Co 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
    241
  • 날짜
    2000-12-29
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • 데이터 추가 비고
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • 원인
    An ecri member hospital reported that in examining a problem with the bed frame structures mentioned, maintenance staff discovered a crack in the corner joint weld (ie, an area where two or more pieces of metal are welded). the hospital claims that the units were in use for about six months only. the nurses were not aware of the problem, and as a result, the hospital can not determine when the cracks occurred. the hospital says that the manufacturer hard changed the bed structures and that no other unit presented the problem.
  • 조치
    ECRI makes the following recommendations: (1) Periodically inspect all welds in cribs for wear or cracks. The HARD manufacturer recommends annual inspections, but ECRI believes that semiannual inspections are more appropriate. The manufacturer HARD says it will inspect the beds produced by them in their hospital for free. (2) Remove any cracks where any cracks appear and contact your local dealer or directly with the HARD manufacturer for replacement of the frame. ECRI states that preventive maintenance procedures are available in a free manual provided by the manufacturer HARD; the manual also includes prior risks and crib alerts, as well as the current FDA product regulations. Contact your local dealer or directly with the HARD manufacturer by mail for the manual or to inquire about inspection services.

Device

Pediatric Bed Structure Model E-1943 HARD

Manufacturer

HARD Mfg Co Inc
  • Source
    ANVSANVISA