Events

Device Recall 9131 Defibrillator Electrodes 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cardiac Science Corporation 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
    72824
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0829-2016
  • 사례 시작날짜
    2016-01-14
  • 사례 출판 날짜
    2016-03-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-12-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142304
  • 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
    Defibrillation electrodes may increase electrical impedance over time. if impedance becomes too high, the aed will fail the electrode self-test and it will not be rescue ready, the aed status indicator will be red and the aed will beep. this is normal behavior when the impedance limit is exceeded. the high impedance electrodes require replacement.
  • 조치
    Cardiac Science sent an Urgent: Voluntary Medical Device Recall letter dated January 2016 starting on January 14, 2014. The letters were either addressed to Distributor or Customer. The letter described the problem and the product involved in the recall. Requested consignees to replace any electrodes from the lot 141125-02 and return them to Cardiac Science. Furthermore, it advised consignees to contact their customers or members of their facilities who need to be made aware by providing a copy of the notification letter and replacement electrodes if they were a distributor. For questions contact Cardiac Science Technical Support at 1-800-426-0337, option 1 in USA or +1-262-953-3500 OUS or via e-mail a9131cardiacscience.com. For questions regarding this recall call 800-426-0337.

Device

Device Recall 9131 Defibrillator Electrodes
  • 모델명 / 제조번호(시리얼번호)
    Lot No. 141125-02
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US all states including PR except ND & RI. International Distribution to Argentina, Australia, Belgium, Bermuda, Canada, Chile, Colombia, Ecuador, France, Germany, Hong Kong, Iceland, Ireland , Israel, Lebanon, Malaysia, Malta, Norway, Oman, Philippines, Poland, Qatar, Romania, Russian Federation, Singapore, Slovenia, Sweden, Turkey, United Kingdom.
  • 제품 설명
    9131-001 Defibrillation Electrodes, Lot No. 141125-02 || Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs || Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The electrodes are intended for short term use (<8 hours) and must be used before the expiration date listed on the packaging. The AED electrodes are used for emergency treatment of cardiac arrest patients over 8 years of age or greater than 55 pounds. The user assesses the patient s condition and confirms that the patient is unconscious, pulseless and is not breathing prior to applying the electrodes to the skin.
  • Manufacturer
    Cardiac Science Corporation

Manufacturer

Cardiac Science Corporation
  • 제조사 주소
    Cardiac Science Corporation, N7 W22025 Johnson Dr, Waukesha WI 53186-1856
  • 제조사 모회사 (2017)
    Cardiac Science Corporation
  • Source
    USFDA