Events

Welch Allyn AED 20 Defibrillator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 MRL, Inc., A Welch Allyn Company 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    31934
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0806-05
  • 사례 시작날짜
    2005-04-28
  • 사례 출판 날짜
    2005-05-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-09-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38777
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Automated External Defibrillators (Non-Wearable) - Product Code MKJ
  • 원인
    The welch allyn aed 20 product may display a 'defib comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ecg and deliver the appropiate therapy.
  • 조치
    Urgent Medical Device Recall letters dated 04/28/2005 were sent to the direct accounts informing them of the possibility in a terminal failure due to the radio frequency interference generated inside the AED 20 resulting from an intermittent electrical short. Any questions were directed to Welch Allyn-MRL Technical Support at 1-800-462-0777.

Device

Welch Allyn AED 20 Defibrillator
  • 모델명 / 제조번호(시리얼번호)
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  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Nationwide and internationally to Australia, Canada, China, France, Germany, Ireland, Israel, Malaysia, the Middle East, New Zealand, the Philippines, Poland, Singapore, South America, South Korea, Switzerland and the United Kingdom.
  • 제품 설명
    Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED20, part number 972200E
  • Manufacturer
    MRL, Inc., A Welch Allyn Company

Manufacturer

MRL, Inc., A Welch Allyn Company
  • 제조사 주소
    MRL, Inc., A Welch Allyn Company, 1000 Asbury Dr Ste 17, Buffalo Grove IL 60089-4551
  • Source
    USFDA