Events

Device Recall IntelliVue Clinical Information Portfolio 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
    59297
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3111-2011
  • 사례 시작날짜
    2011-07-08
  • 사례 출판 날짜
    2011-08-31
  • 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=102145
  • 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
    Display, cathode-ray tube, medical - Product Code DXJ
  • 원인
    Under certain circumstances, edits to an order can result in unintended scheduled interventions on the intellivue clinical information portfolio. a patient may receive interventions or additional medication doses that are not intended.
  • 조치
    Philips Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated July 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers are asked to follow the guidelines in the "Action to be taken by Customer/User" section of the Urgent Medical Device Correction Notice. Philips has developed a software upgrade to address this problem in the short term. This upgrade will be available immediately. This software upgrade will be performed by Philips service personnel. While customers await the correction of their devices, customers are instructed to follow the instructions for use for the device, which includes the directions to: 1. Always use the medication administration record (MAR) in determining patient care. 2. Always review orders and pending administrations in the administration record after any changes to an order are stored. For the longer term, Philips is developing safeguards intended to minimize the potential for similar errors resulting from order changes and upgrade to be available in September 2011. If you need any further information or support concerning this issue, please contact your local Philips representative.

Device

Device Recall IntelliVue Clinical Information Portfolio
  • 모델명 / 제조번호(시리얼번호)
    Software version: D.03, E.0, or E.01 of the software
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY HONG KONG, IRELAND, ITALY, KENYA, LATVIA, MALAYSIA, NETHERLANDS, NORWAY, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • 제품 설명
    Philips Medical: || 865047 IntelliVue Clinical Information Portfolio Release D.03 || 865209 IntelliVue Clinical Information Portfolio Release E.00 and E.01 || 865300 IntelliVue Clinical Information Portfolio NICU Link || Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage.
  • 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