Device Recall VSeries 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
    68582
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2059-2014
  • 사례 시작날짜
    2014-05-19
  • 사례 출판 날짜
    2014-07-16
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-04-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Ecg interpretation feature issues. false measurements reported when the algorithm cannot determine p wave or qrs axis. the median complex report displays the representative beat 25% larger than actual signal input. when a patient date of birth is imported from an external source, the ecg interpretation algorithm uses the default age of 50, and interpretive statements may be incorrect.
  • 조치
    Mindray issued "Urgent: V-Series Monitoring System Corrective Action" notices dated May 19, 2014, to customers that received the affected product via certified mail with return receipt verification. The notification informs the customer of the issues with the affected product and how to identify the affected product. The notification recommends that customers discontinue use of the 12-lead ECG interpretation feature until a software correction is available (anticipate August 2014). A point of contact is provided to customers in case they have questions. For further questions please call 1-800-288-2121.

Device

  • 모델명 / 제조번호(시리얼번호)
    Part Number (P/N): 0998-00-1800-101 and 0998-00-1800-201 with software version 2.4.1.18 in use with 12-lead ECG Module, P/N:0998-00-1804-01 and 0998-00-1804-02.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including the states of Louisiana, New Jersey, Montana, South Carolina and Wyoming.
  • 제품 설명
    V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
  • Manufacturer

Manufacturer