Events

Device Recall Advisor Vital Signs Monitor with Capnography 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smiths Medical PM, 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
    31505
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0831-05
  • 사례 시작날짜
    2005-03-16
  • 사례 출판 날짜
    2005-05-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-12-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38868
  • 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
    Electrocardiograph - Product Code DPS
  • 원인
    Altitude testing of the advisor with capnography module found the co2 (end tidal and inspired) values are incorrect when the advisor is configured to display in the relative units of percent (%) at elevations above 4,100 feet (at standard temperature pressure). the % co values displayed will be lower than the actual co2 value.
  • 조치
    On March 16, 2005, customers were emailed Safety Action Bulletin 05-003 informing them of the low CO2 (End Tidal and Inspired) measurements in percent (%) and urging them to use mmHg or kPa as the unit of measurement . In addition, a Technical Worksheet will be distributed to customers who request a software upgrade. The Technical Worksheet will instruct them how to perform the software upgrade which corrects the CO2 measurements (End Tidal and Inspired) in percent (%).

Device

Device Recall Advisor Vital Signs Monitor with Capnography
  • 모델명 / 제조번호(시리얼번호)
    serial no. 706607001
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    CA and NY within US. Mexico, Argentina, Columbia, Chile, Brazil, Ecuador, Guatemala and Pakistan.
  • 제품 설명
    Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925674320.
  • Manufacturer
    Smiths Medical PM, Inc.

Manufacturer

Smiths Medical PM, Inc.
  • 제조사 주소
    Smiths Medical PM, Inc., N7w22025 Johnson Dr, Waukesha WI 53186-1856
  • Source
    USFDA