Events

Non-rechargeable Lithium Batteries used with Lifepak 500 Automated External Defibrillators (Nonrechargeable Lithium Batteries used with Lifepak 500 Automated External Defibrillators). Identifier: Parts Nos .: (1) from 3005380-000 to 3005380-006, (2) 3005380-014; Date Codes: (1) from 9837 to 9920, (2) 9812, from 9901 to 9905 within Medtronic Physio-Control 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Medtronic Physio-Control Corp 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
    283
  • 날짜
    2000-09-29
  • 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
    To date, the existence of 02 registrations of said product in Brazil on behalf of the Companies, UNITED MEDICAL LTDA and MEDTRONIC COMERCIAL LTDA, has been detected. BRASIL - 15.01.2002 - The Company UNITED MEDICAL LTDA, further sells said product, and is finalizing the process of requesting cancellation of registration with ANVISA. BRAZIL - 25.07.2002 - The company MEDTRONIC COMERCIAL LTDA, reports that 46 units were imported, and only 24 units belong to the lot / series that presented problems (30.01.2002). In addition, all replacements and upgrades have been successfully completed.
  • 원인
    Medtronic physio-control received 6 reports of battery failure caused by battery cell rupture. medtronic physio-control stated that each failure involved the rupture of only one battery which led to the opening / rupturing of the packaging box. two of the six reports said that this rupture caused minor injuries to the defibrillator operator, including respiratory irritations and first-degree burns. medtronic physio-control initiated a correction by correspondence dated july 10, 2000.
  • 조치
    Make sure that you have received the July 10, 2000 correspondence and Medtronic Physio-Control replacement batteries. Identify the affected product by removing the battery from the Lifepak 500 automated external defibrillator (AED) to check the part number and date code. If the battery number does not match the numbers of the affected batteries, the battery can be reinstalled. If the battery number matches the affected battery numbers, remove it from use and install a new battery supplied by Medtronic Physio-Control. After installing the new battery, turn the AED on to advise the unit that a new battery has been installed. After 10 seconds, make sure the message "Connected Electrodes" appears. The unit is ready for use. The company estimates that the recall date for this recall is September 30, 2000. For more information, contact your Medtronic Physio-Control representative or technical support at (1-425) 867-4000 in the United States

Device

Non-rechargeable Lithium Batteries used with Lifepak 500 Automated External Defibrillators (Nonre...

Manufacturer

Medtronic Physio-Control Corp
  • Source
    ANVSANVISA