Events

Device Recall LIFEPAK 500 Automated External Defibrillator (AED) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Physio Control, 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
    65565
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1773-2013
  • 사례 시작날짜
    2013-06-12
  • 사례 출판 날짜
    2013-07-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-09-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119584
  • 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 lifepak 500 automated external defibrillator (aed) could be susceptible to malfunction due to an assembly error. if affected, the malfunction would be the result of internal shorting on a printed circuit board assembly and could render the device inoperable.
  • 조치
    The firm, Physio-Control Inc., contacted their consignees by telephone or email starting on June 13, 2013 and sent and/or delivered an "URGENT MEDICAL DEVICE CORRECTION" letter dated June 2013 to its customers. The letter described the product, problem and actions to be taken. A Physio-Control representative will be contacting the customers by direct visit, telephone, or email you to coordinate the replacement of their device(s). Customers with questions regarding this notification, please call Physio's Technical Support at 1-800-442-1142, 6:00 a.m. to 4:00. pm. (Pacific), Monday-Friday.

Device

Device Recall LIFEPAK 500 Automated External Defibrillator (AED)
  • 모델명 / 제조번호(시리얼번호)
    PART NUMBERS:  3011790-001568, 3011790-001574, 3011790-001627, 3011790-001634, and 3011790-001650.  SERIAL NUMBERS OUTSIDE the US: 41232265, 41232267, 41232269, 41232270, 41232271, 41232272, 41238207, 41238208, 41301145, 41301370, 41301371, 41301372, 41301373, and 41301374.   SERIAL NUMBERS IN THE US: 41134905, 41134906, 41134907, 41135982, 41135983, 41135984, 41135991, 41135992, 41135993, 41135994, 41135995, 41135996, 41135997, 41135998, 41135999, 41136000, 41136001, 41136002, 41136003, 41136004, 41136005, 41136006, 41136007, 41136008, 41136009, 41136010, 41136011, 41136012, 41136013, 41136014, 41136015, 41136016, 41136017, 41136018, 41136019, 41136020, 41136021, 41136022, 41136023, 41136024, 41136025, 41136026, 41136027, 41136028, 41136029, 41136030, 41136031, 41136033, 41136034, 41136035, 41136036, 41136037, 41136038, 41136039, 41136040, 41136060, 41136061, 41136062, 41136063, 41136064, 41136065, 41136066, 41136067, 41136068, 41136069, 41136070, 41136071, 41136072, 41136073, 41136074, 41136075, 41136076, 41136077, 41136078, 41136079, 41136092, 41136093, 41136094, 41142873, 41145359, 41145360, 41145361, 41145362, 41145363, 41145364, 41145365, 41145366, 41145367, 41145368, 41145369, 41145370, 41145371, 41145372, 41145373, 41145374, 41145375, 41145376, 41145377, 41145378, 41164115, 41232002, 41232003, 41232004, 41232005, 41232249, 41232250, 41232251, 41232252, 41232253, 41232254, 41232255, 41232256, 41232257, 41232258, 41232259, 41232260, 41232554, 41239182, 41239183, 41239184, 41239185, 41239186, 41239187, 41239188, and 41239189.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: US (nationwide) including states of: IL, MA, NC, ND, NY, PA, RI, TX, WA, and WI; and country of: Canada.
  • 제품 설명
    The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm || and indicates whether or not it detects a shockable rhythm. || The LIFEPAK 500 AED is intended for use by personnel who are authorized by a physician/medical director and is intended for use in the pre-hospital and workplace and community environments.
  • Manufacturer
    Physio Control, Inc.

Manufacturer

Physio Control, Inc.
  • 제조사 주소
    Physio Control, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA