Events

Infinity(R) Acute Care System (IACS) Monitoring Solution (M540) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Draeger Medical, 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
    60155
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0263-2012
  • 사례 시작날짜
    2011-10-18
  • 사례 출판 날짜
    2011-11-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-04-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104618
  • 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
    During product training on the infinity(r) acute care system (iacs) monitoring solution (m540) it was discovered that the weight-based drug dosage calculation may indicate incorrect recommended values. in addition, a misalignment of ecg and art waveforms delivered from an infinity(ro acute care system (iacs) monitoring solution (m540) was observed on the infinity central station.
  • 조치
    The firm initiated their recall of this device on October 17, 2011 by issuing a letter to the consignee instructing customers to follow the Instructions for Use and use the Infinity Central Station only for remote assessment of a patient's status. They recommend that you do not consider the waveforms on Infinity Central Station for primary diagnosis purposes. In case of a high priority alarm situation, "Check the patient and treat if necessary". If the misalignment issue is observed, it can be cleared by undocking and redocking the M540 or by changing the order of waveforms displayed on the Cockpit screen (or any other change to the auto display screen layout).

Device

Infinity(R) Acute Care System (IACS) Monitoring Solution (M540)
  • 모델명 / 제조번호(시리얼번호)
    Catalog number MS25510
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution - IL
  • 제품 설명
    Infinity(R) Acute Care System (IACS) Monitoring Solution (M540) - Physiological Patient Monitoring Solution || Networked solution/system used to monitor patients' vital signs and therapy, control alarms, review Web-based diagnostic images, access patient records, and scale up functionality based on patient acuity level.
  • Manufacturer
    Draeger Medical, Inc.

Manufacturer

Draeger Medical, Inc.
  • 제조사 주소
    Draeger Medical, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • 제조사 모회사 (2017)
    Stefan Dräger GmbH
  • Source
    USFDA