Events

LCD MONITOR SONY, Model LMD-1951 MD Registration 80102510940, Serial numbers: 3000038 to 3004884, 3100035 to 3100058 and 3100065 to 3100145 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA; Sony Corporation 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
    1551
  • 날짜
    2015-03-11
  • 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
    The company clarifies that the use of the affected equipment may cause the procedure to be suspended due to the shutdown defect mode of the monitor, requiring an alternative technique during the procedure if the monitor turns off and does not allow viewing.
  • 원인
    Vr medical informs that, through a statement issued by sony brazil, it was informed of the need to replace the power plate of the anvisa 80102510940 lcd monitors. this need arises from the fact that the monitors do not turn on or lose the image during the clinical use. according to manufacturer's investigation the problem is due to a disconnection of the internal power supply caused by failure in the integrated circuit of the power board. it was reported that up to now in brazil there have been no reports of adverse events associated with this mode of defect.
  • 조치
    The company directs users who own affected equipment to follow the guidelines outlined in the SONY Communiqué: 1) If you have an AC adapter (AC-110MD) for each of your affected monitors, only use the AC adapter when the monitors are in use; 2) If you do NOT have an AC adapter (AC-110MD) for each of the affected monitors, stop using the operation monitor until the permanent corrective measure is deployed. For more information, access the appendix Customer Information - Sony LCD Monitor

Device

LCD MONITOR SONY, Model LMD-1951 MD Registration 80102510940, Serial numbers: 3000038 to 3004884,...

Manufacturer

VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA; Sony Corporation
  • Source
    ANVSANVISA