Events

Defibrillator - Implantable Cardioverter ATLAS II AND EPIC II 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 St. Jude Medical Ab || St Jude Medical || St. Jude Medical Operations Sdn Bhd || St. Jude Medical. Cardiac Rhythm Management Division 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
    A1604-158
  • 사례 연번
    2008DM-0001674
  • 날짜
    2017-04-06
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=94
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer through routine electrical tests has identified faults originating in the manufacturing process, by assembling slightly larger vibrators that could damage the insulation coating of the high voltage capacitor, which would cause a narrowing of the distance between the two adjacent components, resulting in possible leakage of electrical current or an electric arc between the high-voltage capacitor and these components, leading to the occurrence of potential adverse events on patients.

Device

Defibrillator - Implantable Cardioverter ATLAS II AND EPIC II
  • 모델명 / 제조번호(시리얼번호)
    CD1377-36C, CD1377-36QC, CD2377-36C and CD2377-36QC
  • 제품 설명
    Designed to administer ventricular antitachycardia and ventricular defibrillation for the automatic treatment of ventricular arrhythmias that endanger the life of the patient. Addition of indication: indication for magnetic resonance imaging, for MRI cardioid defibrillators models CD2377-36Q, CD2377-36QC, CD1377-36Q, CD1377-36QC and QUADRAASSURA cardioid defibrillators models CD3367-40QC, CD3367-40Q and QUADRAASSURA MP models CD3371-40QC, CD3371- 40Q. The cardiofibrillators FORTIFY ASSURA DR models CD2359-40Q, CD2359- CD2359-40QC, and FORTIFY ASSURAVR models CD1359-40Q, CD1359-40QC; they are conditional to magnetic resonance, the use of these devices conditionally safe in the MRI environment if a conditional DAI system is used to complete MRI.
  • Manufacturer
    St. Jude Medical Ab || St Jude Medical || St. Jude Medical Operations Sdn Bhd || St. Jude Medical. Cardiac Rhythm Management Division

Manufacturer

St. Jude Medical Ab || St Jude Medical || St. Jude Medical Operations Sdn Bhd || St. Jude Medical...
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA