Events

Ultrasound equipment for EPIQ diagnosis, EPIQ models 5 and 7. Registration: 10216710275. Class III. Products Affected: EPIQ 7 - Version 1.3.2 or lower with Pediatric Cardiology option. EPIQ 5-US814C0626 / US914C0627 / US914C0261 / USO14C0601 / USO14C0602 / USO14C0603 / USO14C0604 / USO14C0605 / USO14C0606 / US215C0175 / US215C0429 / US215C0430 / US215C0432 / US215C0432 / US215C0434 / US215C0434 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
    1576
  • 날짜
    2015-05-08
  • 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 conclusion of the risk analysis performed by the company was not acceptable for pediatric cardiology and acceptable for the rest of the applications. If a health care provider makes a clinical decision based on a calculated Cardiac Index using an incorrect BSA without considering other indicators of cardiac function, the result may be an incorrect diagnosis and / or delayed or incorrect therapy.
  • 원인
    When the epiq 5 and 7 ultrasound system is set to "metric" and the weight and / or height are reported, a unit conversion error may result in incorrect calculation of the body surface area (bsa) of the patient. when using only the patient's weight to calculate bsa, which is standard practice for patients below 2 years, the result would bring a very high value, by a factor of approximately 1.7. the cardiac index calculated using this value would be very low, by a factor of 1.7. an error of this magnitude may not be immediately detected by the user.
  • 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. If you have an affected software version and the Pediatric option is enabled, contact your local Philips representative to schedule an update of your software. ////// Until your software can be updated, 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 once before including a scan. 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 on the Metric units instead of enabling the English units. If a height or weight value has to be reported in 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 uploading the data of any examination will prevent the data from this examination from being changed.

Device

Ultrasound equipment for EPIQ diagnosis, EPIQ models 5 and 7. Registration: 10216710275. Class II...

Manufacturer

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