Events

Device Recall Mindray DPM 7 Monitor 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
    71934
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2737-2015
  • 사례 시작날짜
    2015-07-27
  • 사례 출판 날짜
    2015-09-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-05-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139403
  • 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
    The dpm 7 monitors may display a black screen.
  • 조치
    Mindray sent an Urgent Medical Device Correction / DPM 7 Monitor letter, dated July 27, 2015, to their affected customers via certified mail and return receipt. The letter identified the problem as well as the affected product, adverse effects on patients, and corrective action. The firm will repair the potentially affected monitor at no cost to the customer. Customers are to contact their Mindray Service Representative at 1-800-288-2121 to arrange for the repair.

Device

Device Recall Mindray DPM 7 Monitor
  • 모델명 / 제조번호(시리얼번호)
    Lot #14A18, PN: 6800F-PA00001, Serial Numbers: DU- 46002583, DU-46002587, DU-46002588, DU-46002589, DU-46002592, DU-46002594, DU-46002595, DU-46002596, DU-46002599, DU-46002600, DU-46002601, DU-46002605 and DU-46002606
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed to the states of CT, IA, KY, MS, PA, UT and WA.
  • 제품 설명
    Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) || Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia detection, ST Segment analysis, and heart rate.
  • Manufacturer
    Mindray DS USA, Inc. dba Mindray North America

Manufacturer

Mindray DS USA, Inc. dba Mindray North America