Events

HeartStart MRx/MRxE M3535A and HeartStart XL M4735A 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Philips Healthcare 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
  • 날짜
    2009-04-24
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20090425.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • 데이터 추가 비고
    Press release
  • 원인
    Recall of automated external defibrillators the department of health (dh) today (april 24) alerted the public of a voluntary recall by the manufacturer of two models of automated external defibrillator (aed) which have switch problem. the affected models are heartstart mrx/mrxe m3535a and heartstart xl m4735a. investigation conducted by the manufacturer, philips healthcare, revealed that failures are more likely to occur in devices that have been exposed to high heat and humidity, which contribute to accelerated internal degradation of switch components over time. about 270 aed of the two models have been introduced to hong kong, mostly to public and private hospitals. philips healthcare has alerted its purchasers. people should not use the aed of the affected models and contact the company by calling its hotline 2876 7578 for advice. dh has not received any report of adverse events arising from this issue and will closely monitor the recall. ends.

Device

HeartStart MRx/MRxE M3535A and HeartStart XL M4735A
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Press release: Recall of Automated External Defibrillators
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • 제조사 모회사 (2017)
    Philips
  • Source
    DH