Events

V Series Monitor, Mindray DS USA, Inc 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Mindray DS USA, Inc. dba Mindray North America 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
    66755
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0389-2014
  • 사례 시작날짜
    2013-10-07
  • 사례 출판 날짜
    2013-11-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-04-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123285
  • 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
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • 원인
    Mindray has identified an issue with v series monitor where the v dock power pins connecting the v series monitor to the v dock may lose spring tension, potentially causing the screen to temporarily go blank, lose communication with the central station monitor (when one is in use) or shut down. no patient related events have been reported to mindray concerning the issue.
  • 조치
    Mindray sent an Urgent Corrective Action letter dated October 7, 2013 to all of their customers. The letter identified the affected product, problem and actions to be taken. Customers should contact their Mindray Service Representative at 1-800-288-2121 Monday through Friday from 830 am to 530 pm to arrange for the replacement of the affected product.

Device

V Series Monitor, Mindray DS USA, Inc
  • 모델명 / 제조번호(시리얼번호)
    V Series Montor p/n 0998-00-1801-01 and the associated V Dock , p/n 0998-UC-180-01
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA Nationwide
  • 제품 설명
    Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) || Product Usage: || The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the V Series include the monitoring of the following human physiological parameters: 1) ECG waveform derived from 3, 5, 6 and 12 lead measurements 2) Heart Rate 3) Pulse Oximtery 4) ST Segment 5) Arrhythmia Detection 6) Non Invasive Blood Pressure (IBP) 7) Cardiac Output (CO) 8) Respiratory Gases 9) Respiration Rate 10) Temperature The V series monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
  • Manufacturer
    Mindray DS USA, Inc. dba Mindray North America

Manufacturer

Mindray DS USA, Inc. dba Mindray North America