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EXTERNAL DEFIBRILLATORS: LIFEPAK 1000 (Anvisa Reg. 10339190300). UNITS MANUFACTURED IN 2007. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Physio-Control Inc.; Medtronic Comercial Ltda. 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
    931
  • 날짜
    2008-07-01
  • 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 Medtronic Commercial Ltd., the defibrillators described above were fabricated with a component that may fail due to a higher electrical leakage than normal in this item, which can cause the display to weaken and possibly the total disappearance of the data. The devices identified were manufactured in a limited number between January and December 2007 and the company said it considers it unlikely after an engineering review that the display or performance of LIFEPAK 1000 is affected by this problem. As an additional check the company is running functional tests to confirm the engineering analysis.
  • 원인
    Possibility of failure of the equipment display.
  • 조치
    Users should identify any risk-defibrillators they may have, but may continue to use them normally. It is recommended that devices be set to "auto-analyze" mode by selecting "analyze" in the device menu. If you detect that the information on the LIFEPAK 1000 defibrillator display begins to weaken or disappear completely, you must inform the product registration holder in Brazil immediately (Medtronic Comercial Ltda - Tel: (11) 2182-9200). If the display erases during use, the recommended measures are as follows: (1) Continue to use LIFEPAK 1000 to treat the patient (voice and sound messages work normally); (2) If the equipment is not set to "auto-analyze," use the right-hand key at the bottom of the screen to select Analyze.

Device

EXTERNAL DEFIBRILLATORS: LIFEPAK 1000 (Anvisa Reg. 10339190300). UNITS MANUFACTURED IN 2007.

Manufacturer

Physio-Control Inc.; Medtronic Comercial Ltda.
  • Source
    ANVSANVISA