Events

Ultrasonic diagnostic equipment EPIQ, Model EPIQ 7, hazard class III, serial numbers: US115B0096 / US914B0277. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Philips Medical Systems Ltda.; Philips Medical Systems Nederland B.V. 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
    1585
  • 날짜
    2015-05-13
  • 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 the company, if a health care provider makes a clinical decision based on a Cardiac Index calculated using an incorrect BSA without considering other indicators of cardiac function, the result may be an incorrect diagnosis and / or delayed or incorrect therapy. ///// ** this action will be implemented in conjunction with 2 other FCOs reported: FCO79500336- Epiq 5 (Pediatric Conversion Correction) FCO79500337- Epiq 7 (Pediatric Conversion Correction).
  • 원인
    According to the record holder there is an error in the conversion of the unit weight and height, in the metric setting, in the calculation for the patient's body surface area that results in incorrect calculation.
  • 조치
    The registry holder will perform a field correction of the equipment and advises users to verify that the version of the software used is affected. Philips corrected this problem in versions 1.3.3 and higher. If you have a software version affected, contact your local Philips representative to schedule an upgrade of your software. Note: If Pediatric Cardiology is enabled, please contact your local Philips representative urgently to schedule an update of your software in accordance with FCO79500337. Until your software can be upgraded, the situation can be avoided by ensuring that the Patient Data Units setting is set to "English" units. If this setting is not acceptable to your institution and you need to use the "Metric" units, you can avoid the problem by ensuring the following: 1. After turning on the system, open the Patient Data screen before including an examination. This will put the Patient Data screen back in an appropriate status and the problem will not occur. 2. Ensure that the Patient Data screen is maintained in the Metric units instead of English units. If a height or weight value has to be reported in English [English] units, then it must be converted to Metric manually to avoid the problem. Finally, ensuring that the Patient Data screen is using the Metric units before loading the data of any examination will prevent the data from this examination from being changed.

Device

Ultrasonic diagnostic equipment EPIQ, Model EPIQ 7, hazard class III, serial numbers: US115B0096 ...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems Nederland B.V.
  • 제조사 모회사 (2017)
    Philips
  • Source
    ANVSANVISA