Events

Integris Monitor Arms 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
    365
  • 날짜
    2002-01-16
  • 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
    The brackets of this monitor are associated with 03 potential risks: (1) when the arm mounting pins loosen, the monitor may fall off the arm. this risk can occur when the professional tries to move the monitor horizontally or vertically. (2) mechanical failure of the arm mounting inner knee may cause the monitor to fall when it comes from the lower position to the rest position. this risk can occur when the professional tries to turn the arm vertically. (3) if the mounting was improperly installed the monitor may fall from the stand. this risk can occur when the professional tries to move the monitor horizontally or vertically. any of these problems can cause injury to the patient or operator or damage to the monitor and the arm of the patient. the manufacturer initiated a correction by an urgent health product correction letter dated december 4, 2001.
  • 조치
    Make sure you received the Health Product Urgent Correction letter dated December 4, 2001 and the 0.20-inch-inch pin-gauge pin from Hill-Rom. The manufacturer requires you to discontinue use of any monitor arm in your inventory until Hill-Rom's employee / inspector staff inspects and verifies that the unit is properly mounted. If it is essential to continue using the product Hill-Rom recommends that you notify the practitioner of the potential hazards described above, position the monitor as far as possible from the area where the patient will be and perform the inspection of the monitor arm. To inspect the monitor arm use the pin to check for clearance between the bottom of the base and the rotating adapter. If the pin comes fully into either side of the swivel adapter, remove the monitor arm from its service immediately. The manufacturer requests that you send the copy of the Urgent Correction of Health Products letter to all relevant personnel. In theory, you should have already been contacted by Hill-Rom regarding this correction. If this did not happen or you need more information, contact your local representative.

Device

Integris Monitor Arms

Manufacturer

Hill-Rom Co Inc A Hillenbrand Industry
  • Source
    ANVSANVISA