Events

Heartstart XL Defibrillator - Model: M4735A - ANVISA Registry # 10216710063 - Hazard Class III 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Philips Medical Systems 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
    1199
  • 날짜
    2012-09-19
  • 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
    Philips recommends the following measures: • Operate the XL with AC power instead of battery power only. • If you need to operate the XL with battery power only, make sure the battery is of a different Manufacturing Date (it should not have code R-2011-12 for the Date of Manufacture). • If you can not operate with AC power only or find a battery with a date of manufacture other than the one identified above, use an alternative energy source for treatment or therapy (eg, defibrillator / standby monitor). Access security letter to customers and lots involved in: http: //portal.anvisa.gov.br/wps/wcm/connect/a71f70004d731b5a890ae9c116238c3b/Aviso_de_Seguranca_FCO86100117A.pdf? MOD = AJPERES
  • 원인
    If the xl defibrillator / monitor (m4735a) is used in a patient when ac power is not in use, with a battery that may fail, the device may shut down unexpectedly without providing the user with a warning message or low battery tone. there is potential for harm to the patient if the xl shuts off or becomes inoperable when in clinical use to provide therapy (ie defibrillation or non-invasive cardiac pacing) note: the xl is capable of running on ac power without a battery.
  • 조치
    corrective action: Safety Notice (FSN) informing affected customers about the possible problem and action to be taken, as well as arranging for the replacement of affected customers' batteries at no charge as soon as new production is available. A Philips Healthcare representative will contact customers with the affected batteries to arrange replacement. Any information or support regarding this issue, please contact us on 0800 701 77 89, Monday to Saturday service from 7am to 7pm.

Device

Heartstart XL Defibrillator - Model: M4735A - ANVISA Registry # 10216710063 - Hazard Class III

Manufacturer

Philips Medical Systems
  • 제조사 모회사 (2017)
    Philips
  • Source
    ANVSANVISA