Events

Intensive Care Ventilator Engstrom Carestation, Risk Class III, Model: Engstrom Carestation and Engstrom Pro, Brand: GE Healthcare, Registered: 80071260230, Serial Number: Engstrom CBCN01062 to CBCQ01396 (SEE APPENDIX). Accessory trolleys sold separately from Engstrom fans are also affected from October 2009 to September 2011. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 GE Healthcare do Brasil; DATEX-OHMEDA 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
    1519
  • 날짜
    2015-02-04
  • 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
    According to the record holder, failure of the caster assembly equipment may result in fan drop / tilt (imbalance).
  • 원인
    The company informs that specific combinations of engstrom fan casters and bases have been identified that are more likely to fail the caster mounting equipment. failure of the caster mounting equipment may result in fan dropping / tilting (imbalance). a fall / tilt of the engstrom fan may result in serious injury to patients or clinic staff.
  • 조치
    GE Healthcare of Brazil makes it clear that customers can continue to use the Engstrom fan equipment. If the fan equipment is mounted on a cart, make sure that the carriage assembly is fully tightened and shows no signs of damage. If there are signs of damage, contact the GE Healthcare service or your local service representative. GE Healthcare will fix all affected systems at no cost to the customer. A GE Healthcare Technical Services representative will contact you to perform this fix. (SEE CUSTOMER LETTER)

Device

Intensive Care Ventilator Engstrom Carestation, Risk Class III, Model: Engstrom Carestation and E...

Manufacturer

GE Healthcare do Brasil; DATEX-OHMEDA Inc.