Events

Digital System of Image by X-ray INNOVA 2000, 2100IQ, 3100, 4100, 2100IQ, 3100IQ, 4100IQ, Anvisa registry nº 80071260060 and Advantax Hemodynamic Equipment Monoplane Models LC +, LCV +, LCA +, registry Anvisa nº 80071260027. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 GE Healthcare do Brasil Comércio e Serviços para Equipamentos Médico-Hospitalares 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
    915
  • 날짜
    2008-05-07
  • 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
    Attention: Should you experience a sudden drop in the tabletop and loss of vertical movement of your Omega table, contact your GEHC field engineer who will install a fix on your system. However, GE Healthcare recommends: I - Avoid procedures that could cause serious injury to the patient in case of sudden dropping of the table top (eg, procedures using stereotactic frames, needle punches, etc.); that there is a margin in the cables that are connected to the patient III - Do not place the patient's arms or any other objects below or on the side of the table top IV - Do not leave materials on the table that are likely to be damaged in case of fall the table.
  • 원인
    Certain omega iv and omega v tables may fall suddenly and quickly to their lowest position. this situation tends to occur during the vertical movement of the table. immediately after this situation, the vertical movement of the table is blocked. to date, no accident has occurred. currently, only eight of the more than 1,000 global facilities have been affected since july 2003. according to statistics, the likelihood of this problem occurring is low, since in about two million examinations, only eight problems were reported, and no injuries were reported. in such a situation, the system will remain operational, except for the vertical movement of the table. therefore, a procedure can be terminated in this degraded mode. here are some examples of procedures that may present some risk to the patient in the event of a sudden drop in the table: 1. procedures using cerebral stereotactic frames or involving needle punctures; 2. procedures involving the introduction and manipulation of a catheter into an artery; 3. procedures involving dilatation, as well as the use of stent or coil; 4. procedures in which the patient is lying face down on the table with his arms under the table top; 5. procedures in which accessories are placed on the tabletop. to visualize the international alert published by ecri, translated into portuguese, please go to: http://www.Anvisa.Gov.Br/tecnovigilancia/alertas/anexos_2008/alerta_915_traduz .Pdf the charter developed by ge healthcare for its clients can be viewed at: http://www.Anvisa.Gov.Br/tecnovigilancia/alertas/anexos_2008/alerta_915_carta.Pdf.
  • 조치
    GE Healthcare has developed a technical correction to prevent incorrect table movement. This piece will need about an hour to install. This fix will be installed on-site at no additional cost to the customer and will be scheduled according to your availability. For questions or inquiries regarding this subject, please contact the Customer Service Center immediately on 0800 122 345.

Device

Digital System of Image by X-ray INNOVA 2000, 2100IQ, 3100, 4100, 2100IQ, 3100IQ, 4100IQ, Anvisa ...

Manufacturer

GE Healthcare do Brasil Comércio e Serviços para Equipamentos Médico-Hospitalares Ltda