Events

Surgical Light Model P1350 Press Surgical Light. Distributed Units in US and Internationally 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Hill-Rom Co Inc A Hillenbrand Industry 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
    266
  • 날짜
    2002-01-25
  • 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
    One hospital, a member of the ecri accident reporting system, reported loosening and peeling of the screw threads above all of these surgical foci in their inventory. the manufacturer states that these problems would not occur if the threads remain on these special screws. the hospital also reported paint chips in the balance of all these surgical foci, which probably resulted from contact with intravenous fluid bottle holders, shelves with monitors or other equipment. both problems could result in aggravations or contamination of sterile fields. hill-rom is currently contacting customers to see if other outbreaks are affected by the same issues.
  • 조치
    Check in your inventory if you have any other surgical focus. Determine if the bolts are loose and / or if the paint is peeled. At the moment, Hill-Rom is working on a solution to fix both problems. For more information, or to inform the manufacturer of problems with outbreaks in your inventory, contact your local Hill-Rom representative or directly at 1 (812) 934-8189 in the USA. ANVISA has provided the Occurrence Notification Forms on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory. ECRI suggests using a locking wire and / or adhesive to hold the thread in place until Hill-Rom solves this problem. To minimize the risk of ink chipping, ECRI recommends that hospital staff be advised to avoid impact of the equipment with other metal brackets. Touch up or protect with adhesive any area containing peeling paint. If some threads are loose or missing in the foci of your inventory, or need paint for touch-ups, call the manufacturer to receive them. In addition, ECRI suggests positioning the focus elsewhere to reduce the chance of injury or contamination. Additional comment: One week after the publication of this Alert, Ecr i had a telephone conference with Hill-Rom, the company acknowledged this week's suggestions and announcements and requested that any affected customer contact Hill-Rom at mentioned above for information and

Device

Surgical Light Model P1350 Press Surgical Light. Distributed Units in US and Internationally

Manufacturer

Hill-Rom Co Inc A Hillenbrand Industry
  • Source
    ANVSANVISA