Events

NAVIGATOR ANESTHESIA DELIVERY SYSTEM 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Mindray DS USA, Inc., dba Datascope Patient Monitoring 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
    49713
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0319-2009
  • 사례 시작날짜
    2008-10-07
  • 사례 출판 날짜
    2008-12-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-12-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74064
  • 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
    Anesthesia gas-machine - Product Code BSZ
  • 원인
    Two issues have been identified with the as3000 unit. 1. the threadlocker of the caster (wheels) may not have been utilized, which may allow the caster to loosen and possibly separate from the unit. 2. the use of select brands of pre-pack absorber in the absorber canister of the as3000 has been associated, in some cases, with gas leakage around the pre-pack, rather than through the absorber mate.
  • 조치
    Notification (Urgent Product Field Correction) letters were sent to the one consignee on October 7, 2008 by Federal Express overnight delivery.

Device

NAVIGATOR ANESTHESIA DELIVERY SYSTEM
  • 모델명 / 제조번호(시리얼번호)
    Serial Number: AN0804-001 and AN0804-006. Each AS3000 Anethesia Delivery System is labeled with a unique serial number.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Only 2 units are in distribution, both in the same facility in Redondo Beach, CA.
  • 제품 설명
    AS3000 Anesthesia Delivery System. Datascope Patient Monitoring; || A Mindray Global Company. || The AS3000 is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.
  • Manufacturer
    Mindray DS USA, Inc., dba Datascope Patient Monitoring

Manufacturer

Mindray DS USA, Inc., dba Datascope Patient Monitoring