Events

Device Recall Powerheart AED G3 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cardiac Science, Inc. 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
    30704
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0398-05
  • 사례 시작날짜
    2004-11-12
  • 사례 출판 날짜
    2005-01-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-06-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36423
  • 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
    Aeds may contain an electronic component that does not meet its full operating specifications. the aeds with this suspect electronic component may not functionn properly and may interfere with the aed's ability to delivery therapy. in the event that charge noise is presrent it will delay the first defibrillation shock in the 3 shock sequence.
  • 조치
    Cardiac Science will contact customers via telephone to set up a time for Clinical Educator to visit the customer and conduct a field test on each AED. AEDs that fail the field test will be replaced either on the spot or within 24 hours. AEDs failing the test are either removed by the Clinical Educator or are returned to Cardiac Science upon receiving the new AED. Cardiac Science anticipates testing to be done by the end of December 2004.

Device

Device Recall Powerheart AED G3
  • 모델명 / 제조번호(시리얼번호)
    Model no. 9300E serial numbers: 360814 thru 361239, 361320 thru 362359, 362387 thru 362393, 362396 thru 362713, 362916 thru 364194, 364283 thru 364514, and 364606 thru 364914.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Throughout the United States, Canada and Europe.
  • 제품 설명
    Powerheart AED G3 Automated External Defibrillator Model 9300E. Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982.
  • Manufacturer
    Cardiac Science, Inc.

Manufacturer

Cardiac Science, Inc.
  • 제조사 주소
    Cardiac Science, Inc., 5474 Feltl Rd, Minnetonka MN 55343-7982
  • Source
    USFDA