Automatic External Defibrillator (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
    53668
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1683-2010
  • 사례 시작날짜
    2009-10-15
  • 사례 출판 날짜
    2010-05-26
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-12-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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 operators manual may not have adequate information to clearly explain some device behaviors. pressing and holding down the charge or shock button on the responder 2000 for more than 5 seconds causes a "button stuck" error. with the "button stuck" error, the device will automatically exit manual mode and enter monitor mode. the user cannot apply therapy while the device is in monitor mode.
  • 조치
    The firm, Cardiac Science, sent an "Urgent-Medical Device Corrective Action" letter dated October 15, 2009, was sent to customers. The letter describes the product, problem and action to be taken by the customers. Cardiac Science requested GE to provide the end users with the Operator's Manual addendum. The customers are instructed to place the Operator's Manual addendum with their Responder 2000 Operator's Manual for future reference. If you have any questions about your Responder 2000, please contact Cardiac Science technical support at +44.161.926.0011 or our EU Representative, Ludger Moller, MDSS GmbH at +49.511.6262.8630.

Device

  • 모델명 / 제조번호(시리얼번호)
    MODELS: 2025653, 2026109, AND 2026114. The model numbers identify different AED configurations:  MODEL 2025653 is the basic model; MODEL 2026109 is the basic model with pacing; and MODEL 2026114 is the basic model with pacing and SpO2 (oxygen saturation measured by pulse oximetry).  OPERATOR'S MANUAL PART NUMBERS: (the 3 digit number at the end identifies the language in which the manual is written. Regardless of language the manuals are identical in content.) 2026116-001, 2026116-004, 2026116-005, 2026116-008, 2026116-010, 2026116-011, 2026116-012, 2026116-013, 2026116-014, 2026116-015, 2026116-016, 2026116-019, 2026116-022, 2026116-024, 2026116-025, 2026116-026, 2026116-033, AND 2026116-044.   SERIAL NUMBERS: 3100032, 3100033, 3100035, 3100036, 3200074, 3200075, 3200094, 3200107, 3200111, 3200112, 3200113, 3200114, 3200115, 3200116, 3200117, 3200118, 3200119, 3200120, 3200121, 3200122, 3200123, 3200124, 3200125, 3200126, 3200127, 3200128, 3200129, 3200130, 3200131, 3200132, 3200133, 3200134, 3200135, 3200136, 3200137, 3200138, 3200139, 3200140, 3200141, 3200142, 3200143, 3200144, 3200145, 3200148, 3200149, 3200150, 3200151, 3200152, 3200153, 3200154, 3200155, 3200156, 3200157, 3200158, 3200159, 3200160, 3200161, 3200162, 3200163, 3200164, 3200165, 3200166, 3200167, 3200168, 3200169, 3200170, 3200171, 3200172, 3200173, 3200174, 3200175, 3200176, 3200177, 3200178, 3200179, 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  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA and Australia, Brazil, Columbia, Costa Rica, Denmark, Finland, France, Germany, Italy, Korea, Mexico, New Zealand, Panama, Paraguay, Peru, Singapore, South Africa, Spain, and Uruguay.
  • 제품 설명
    Responder 2000 Defibrillator/Monitor || Models: 2025653, 2026109, and 2026114. || Intended use: The Responder 2000 is indicated for the termination of certain fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia. The semi-automatic advisory mode is for use in cardiac arrest in patients of at least 8 years of age. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm. The 3-lead and 5-lead ECG monitoring allows for identification of interpretation of cardiac rhythms or dysrhythmias and calculation of heart rate. The Responder 2000 noninvasive pacing as a therapy is indicated for patients with symptomatic bradycardia or asystole. The pulse oximetry is intended for the continuous external monitoring of arterial oxygen saturation and pulse rate and is indicated for use in any patient who is at risk of developing hypoxemia.
  • Manufacturer

Manufacturer

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