Inspira AIR Balloon Dilation System, size 18X40mm 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Acclarent 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
    2012-03-14
  • 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
    Field safety notice: acclarent inspira air balloon dilation system, size 18x40mm the food and drug administration (fda), united states, has issued a class i recall concerning inspira air balloon dilation system, size 18x40mm (product code: bc1840a) manufactured by acclarent, inc.. fda reported that there is potential for the balloon to not deflate or to deflate slowly, which could result in airway obstruction until the balloon is deflated or removed. prolonged obstruction of the airway may prevent adequate blood oxygenation, which could cause temporary or permanent impairment to the patient. this product may cause serious adverse health consequences, including death. according to the report, the manufacturer has received four reports of incidents, one resulting in patient injury, in which the device has apparently malfunctioned. in each of these cases, difficulty deflating the balloon occurred after the surgeon pulled against resistance in response to the balloon moving distally during dilation. the force applied to the catheter stretched and narrowed the catheter shaft, causing the balloon to be difficult or impossible to deflate. the manufacturer recommends customers immediately discontinue use of the affected products. for details, please visit the following fda website: http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm295488.Htm and http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm295875.Htm if you are in possession of the product, please contact your supplier for necessary actions.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Acclarent Inspira AIR Balloon Dilation System, size 18X40mm
  • Manufacturer

Manufacturer