Events

HeartStart MRx Defibrillator/Monitor 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Healthcare 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
    51673
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1390-2009
  • 사례 시작날짜
    2009-04-10
  • 사례 출판 날짜
    2009-06-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-12-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80929
  • 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
    Spontaneous turn-on which could deplete the battery, rendering the device unusable until power is restored. there is also the possibility of a failure mode in which the device fails to respond to user initiated turn-on, rendering it unusable for monitoring and therapy.
  • 조치
    Philips notified customers via Urgent Medical Device Recall Letter & Notice dated March 2009. Customers are asked to follow the "Actions to be taken by customer/user section of the Urgent Medical Device Recall Notice. In this section, customers are given the following instructions: "During the interim period, as you await the upgrade for your device, you may continue to use the Heartstart MRx. However, to reduce the risk that a spontaneous turn-on could deplete the battery, it is advised that you keep: a charged spare battery with the Heartstart MRx AC power applied, if possible, when the device is not in use You should also consider identifying a readily available backup defibrillator to use in the unlikely event that the device fails to turn on. Devices that exhibit a spontaneous turn-on or failure to respond to user initiated turn on should be removed from service as soon as possible." Philips will replace the therapy switch in affected units free of charge per Mandatory Field Change Order FC086100077. All customers will be contacted by a Philips Healthcare representative to arrange for replacement of the therapy switch in the affected devices.

Device

HeartStart MRx Defibrillator/Monitor
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, Canada, Afghanistan, Argentina, Aruba, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Norway, Oman, Panama, Papua, New Guinea, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudia Arabia, Serbia & Montenegro, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, and Venezuela.
  • 제품 설명
    HeartStart MRx Defibrillator/Monitor, M3535A/M3536A || Is used for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • 제조사 주소
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA