Events

Batteries for XL 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
    63116
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0011-2013
  • 사례 시작날짜
    2012-09-11
  • 사례 출판 날짜
    2012-10-04
  • 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=112615
  • 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
    Heartstart xl defibrillator/monitor (m4735a) used on a patient when ac power is not in use, with a battery that may fail, the device may shut down unexpectedly without providing the user with a low battery warning message or audible tone.
  • 조치
    The firm, Philips Healthcare, sent an "URGENT-MEDICAL DEVICE RECALL/Field Safety Notice" letter dated September 6, 2012 to its customers. The letter describes the product, problem and actions to be taken by the customer and also identifies what action Philips plans to take to remedy the issue. The customers were instructed to operate the XL and AC power instead of battery power alone; use a battery from a different date of manufacture (must not have the R-2011-12 date of manufacture code) if they need to operate the XL on battery power alone; and use an alternative source for treatment or therapy (i.e., backup defibrillator/monitor) if unable to operate with AC power alone or locate a battery with a different date of manufacture than that identified. Phillips will provide a replacement battery(s) to customers as soon as new production is available. If you need any further information or support concerning this issue, contact your local Philips representative or call Quality Specialists,Recalls at 978-687-1501 or email: debra.levasseur@philips.com.

Device

Batteries for XL Defibrillator/Monitor
  • 모델명 / 제조번호(시리얼번호)
    HeartStart XL battery M3516A labeled with Made in Taiwan and an R-2011-12 Date of Manufacture
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (Nationwide) and countries of: AUSTRALIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, FINLAND, FRANCE, GERMANY HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, REPUBLIC OF KUWAIT LEBANON, MACAU, MALAYSIA, MEXICO, NAMIBIA, NETHERLANDS, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, ROMANIA RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, and VIET NAM.
  • 제품 설명
    Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries || The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.
  • 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