Events

Device Recall Powerheart AED, CardioVive AED, GE Responder AED, Nihon Kohden CardioLife AED 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
    60992
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1057-2012
  • 사례 시작날짜
    2012-01-13
  • 사례 출판 날짜
    2012-02-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-09-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107002
  • 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 affected automated external defibrillators (aeds) contains a circuit board manufactured with a component that may fail unexpectedly due to a supplier manufacturing defect. if the component were to fail during a rescue attempt, the aed may not deliver defibrillation therapy.
  • 조치
    Cardiac Science sent an "URGENT-Voluntary Medical Device Recall" letter dated January 13, 2012 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. Customers are advised to immediately return the device to the manufacturing location for repair. The affected devices will receive a hardware correction, and the same serial number device returned to the consignee in most cases. Customers in the US can call 1-888-402-2484 and customers outside the US can call 1-425-402-2482 or email at aed210@cardiacscience.com to arrange delivery of the shipping materials. Customers can also visit www.cardiacscience.com/aed210 for more information about AEDs affected by this recall.

Device

Device Recall Powerheart AED, CardioVive AED, GE Responder AED, Nihon Kohden CardioLife AED
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and Puerto Rico; and to the following countries: Australia, Belgium, Brazil, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Jamaica, Japan, Korea, Kuwait, Malaysia, Maldives, Malta, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Portugal, Qatar, Romania, Russia, Saint Lucia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, Ukraine, and United Kingdom.
  • 제품 설명
    Powerheart G3 Automated External Defibrillators (Non-Wearable) and include the following models: Powerheart 9300A, 9300E, 9300P, 9390A, 9390E; CardioVive 92532, 92533; Nihon-Kohden 9200G, 9231; and GE Responder 2019198, 2023440 AEDs. || The Powerheart AED G3 is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and be able to deliver therapy. The device is intended to be used by personnel who have been trained it is operation. The user should be qualified by training in basic life support or other physician-authorized medical response.
  • Manufacturer
    Cardiac Science Corporation

Manufacturer

Cardiac Science Corporation
  • 제조사 주소
    Cardiac Science Corporation, 3303 Monte Villa Pkwy, Bothell WA 98021-8969
  • 제조사 모회사 (2017)
    Cardiac Science Corporation
  • Source
    USFDA