Events

Device Recall Powerheart 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
    54517
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1247-2010
  • 사례 시작날짜
    2010-02-03
  • 사례 출판 날짜
    2010-04-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88620
  • 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
    A component of the aed device may fail during a rescue attempt and the aed will not be able to deliver therapy.
  • 조치
    The firm began initial notification on 2/3/2010 by sending letters to all affected consignees via USPS certified mail (domestic) and FedEx (international). Also on 2/3/2010 the firm issued a global press release and posted recall information on their website. Customers are instructed to remove their affected units from service, and have been given instructions for returning their affected devices. Replacement AED(s) will be sent as they are available. For questions, please contact the firm's Cardiac Science Support at 1.888.402.2484 or. AED195@cardiacscience.com to arrange for replacement(s).

Device

Device Recall Powerheart AED
  • 모델명 / 제조번호(시리얼번호)
    SERIAL NUMBERS:  4046748, 4171275, 4288092, 4288093, 4288094, 4288095, 4288096, 4288107, 4288108, 4288109, 4288110, 4288111, 4288112, 4288113, 4288114, 4288115, 4288116, 4288117, 4288118, 4288119, 4288155, 4288187, 4288188, 4288189, 4288190, 4288191, 4288192, 4288193, 4288194, 4288195, 4288196, 4288197, 4288198, 4288199, 4288200, 4288201, 4288202, 4288203, 4288204, 4288205, 4288206, 4288207, 4288208, 4288209, 4288281, 4288282, 4288283, 4288284, 4288285, 4288286, 4288287, 4288288, 4288289, 4288290, 4288291, 4288292, 4288293, 4288294, 4288295, 4288296, 4288305, 4288306, 4288312, 4288313, 4288314, 4288316, 4288324, 4288350, 4288351, 4288352, 4288353, 4288354, 4288355, 4288356, 4288357, 4288358, 4288359, 4288360, 4288361, 4288362, 4288363, 4288364, 4288365, 4288366, 4288367, 4288368, 4288369, 4288370, 4288371, 4288372, 4288373, 4288374, 4288375, 4288376, 4288377, 4288378, 4288379, 4288380, 4288381, 4288382, 4288383, 4288384, 4288385, 4288386, 4288387, 4288388, 4288389, 4288390, 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4300380, 4300381, 4300382, 4300384, 4300385, 4300386, 4300387, 4300388, 4300389, AND 4300723.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Distributed to health care and emergency medical personnel and US Gov't/Military in the US and the following 44 countries: AUSTRALIA, BELGIUM, BELIZE, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, DENMARK, EGYPT, FRANCE, GERMANY, GRENADA, GUATEMALA, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, MALAYSIA, MALTA, MEXICO, NETHERLANDS, NORWAY, POLAND, PORTUGAL, PUERTO RICO, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, THAILAND, TRINIDAD, AND GREAT BRITAIN.
  • 제품 설명
    Powerheart 9390E automated external defibrillator. || This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). || Brand name: Cardiac Science. || Product name: Powerheart. || Device Operation: Semi-automatic. || Color: Yellow. || Voice Prompt Level: Extensive.(Extensive voice prompts provide more detailed instruction on device use, pad placement and CPR performance, as compared to the basic prompts.) || CPR Metronome: Yes. || Rescue Ready Indicator: Yes. || Text Display: Yes. || ECG Display: No.
  • 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