Events

Device Recall Kappa 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Draegar Medical Systems, 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
    76862
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1774-2017
  • 사례 시작날짜
    2017-03-28
  • 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=154433
  • 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
    It was reported that a set low o2 alarm does not go off although the measured o2 level is below the alarm limit.
  • 조치
    On March 28, 2017, US consignees were sent an Urgent Medical Recall letter and Customer Reply and Order card. Delta family monitors running software version 10.0 in facilities that also have at least one Scio module will be downgraded to software version VF9.1 as a temporary solution Free of Charge. Draeger Medical Systems, Inc. is developing a new software version to resolve the issue (VF10.1). Once available, all Delta family monitors that were running software version VF10.0 will be upgraded with VF10.1 Free of Charge. For all other countries, the responsible local Draeger Sales and Service will mail the letter and card.

Device

Device Recall Kappa
  • 모델명 / 제조번호(시리얼번호)
    VF10.0 software
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide - US Nationwide distribution in the states of: AL, CA, GA, IL, LA, MA NY, OH, PA, TN, TX and VA and the countries of: AR AT BE BG BN BO BY CA CH CL CO CZ DE EG ES FI FR GB GR HR HU ID IE IL IN IT LT MX MY NL NO NP PA PE PK PL PT RO RS RU SA SE SK TH TR TW UG UZ VN ZA
  • 제품 설명
    Kappa, Catalog Number: MS18853 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Catalog Number(s): MS18597/MS18596/MS18853. || Product Usage: || The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patients medical condition. The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcpO2, which for the neonatal population, is to only be used when the patient is not under gas anesthesia. For combination with Scio gas module: Scio gas module samples breathing gases from adults and pediatrics. The gas module continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the In-finity monitors.
  • Manufacturer
    Draegar Medical Systems, Inc.

Manufacturer

Draegar Medical Systems, Inc.
  • 제조사 주소
    Draegar Medical Systems, Inc., 6 Tech Dr, Andover MA 01810-2434
  • 제조사 모회사 (2017)
    Stefan Dräger GmbH
  • Source
    USFDA