Events

Device Recall Phillips HeartStart MRx Monitor/Defribillator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems, 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
    67459
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1194-2014
  • 사례 시작날짜
    2014-02-18
  • 사례 출판 날짜
    2014-03-12
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125492
  • 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
    When the heartstart mrx.Is used with the q-cpr meter in defibrillation mode, the q-cpr meter may incorrectly display the do not touch the patient icon.
  • 조치
    The firm, Philips Healthcare, sent an "URGENT -Medical Device Correction/Field Safety Notice" letter dated February 2014 on February 18, 2014 to its domestic and foreign customers. The letter describes the product, problem and actions to be taken. The customers were instructed to follow the Action to be Taken by Customer/User section of the attached Field Safety Notice; to continue to use your HeartStart MRx without the Q-CPR Meter attached. If you choose to use the HeartStart MRx with the Q-CPR Meter attached and you observe that the Q CPR Meter is displaying the Do Not Touch the Patient icon at an unexpected time, follow the MRx Instructions for Use and remove the meter from the patient and continue CPR according to your organization's protocol. Philips plans to take to remedy the issue. Philips will provide a software upgrade free of charge. If you have questions regarding this notification or need any further information or support, please contact your local Philips representative or call at 1-800-722-9377.

Device

Device Recall Phillips HeartStart MRx Monitor/Defribillator
  • 모델명 / 제조번호(시리얼번호)
    MRx units with the Q-CPR Meter option B08 and with a serial number within the range: US00100253 and US00571587
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: US (nationwide) and to countries of: ARUBA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA ECUADOR EGYPT FINLAND FRANCE GERMANY HONG KONG INDIA INDONESIA IRELAND ISRAEL ITALY KENYA KOREA, REPUBLIC OF KUWAIT LATVIA LIBYAN ARAB JAMAHIRIYA MALAYSIA MEXICO MOROCCO NETHERLANDS NORWAY OMAN PAKISTAN PHILIPPINES POLAND QATAR RUSSIAN FEDERATION SAUDI ARABIA SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA THAILAND TURKEY UKRAINE UNITED ARAB EMIRATES and UNITED KINGDOM.
  • 제품 설명
    Philips HeartStart MRx Monitor/Defibrillator || Models: M3535A and M3536A with Q-CPR Meter Option B08 || The HeartStart MRx is for use 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 in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
  • Manufacturer
    Philips Medical Systems, Inc.

Manufacturer

Philips Medical Systems, Inc.
  • 제조사 주소
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA