Events

Device Recall Datascope System 98/98xt, CS 100/CS100i and CS 300 IntraAortic Balloon Pump 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Maquet Datascope Corp - Cardiac Assist Division 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
    67815
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1523-2014
  • 사례 시작날짜
    2014-03-21
  • 사례 출판 날짜
    2014-05-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-03-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126390
  • 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
    System, balloon, intra-aortic and control - Product Code DSP
  • 원인
    Potential mechanical failure of the fan assembly associated with the power supply. a fan assembly failure could result in the power supply overheating and cause the iabp to shut down without warning.
  • 조치
    Maquet Inc. sent an Urgent Medical Device Field Correction letter dated March 21, 2014, to all affected customers. The letter identified the affected product, problem, and actions to be taken.. Customers were instructed that their Service Representatiave would contact them to schedule the replacement of the fan assembly at no cost to the customer. Upon completion customers were requested to sign a service repair order to verify satisfactory completion of the work. Customers with questions within Puerto Rico, were instructed to contact Technical Support in Mexico at +52-55-9000-8970, ext 104. For questions regarding this recall call 973-709-7652. A field correction letter was sent out on April 15, 2014 to additional consignees that did not receive the March 15, 2014 letter. Maquet issued press on May 9, 2014.

Device

Device Recall Datascope System 98/98xt, CS 100/CS100i and CS 300 IntraAortic Balloon Pump
  • 모델명 / 제조번호(시리얼번호)
    IABP Model Numbers System 98 0998-00-0446-xx 0998-UC-0446-xx System 98XT 0998-00-0479-xx 0998-UC-0479-xx CS100i 0998-UC-0446Hxx 0998-UC-0479Hxx CS100 0998-00-3013-xx 0998-UC-3013-xx CS300 0998-00-3023-xx 0998-UC-3023-xx
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and approximately 104 countries.
  • 제품 설명
    Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.
  • Manufacturer
    Maquet Datascope Corp - Cardiac Assist Division

Manufacturer

Maquet Datascope Corp - Cardiac Assist Division
  • 제조사 주소
    Maquet Datascope Corp - Cardiac Assist Division, 1300 MacArthur Blvd., Mahwah NJ 07430-2052
  • 제조사 모회사 (2017)
    Getinge AB
  • Source
    USFDA