Events

Device Recall CS 100i 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
    77566
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-2736-2017
  • 사례 시작날짜
    2017-06-16
  • 사례 출판 날짜
    2017-06-23
  • 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=156533
  • 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
    The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.
  • 조치
    Datascope Corp/MAQUET issued a press release on June 16, 2017. Datascope Corp/MAQUET sent an Urgent Product Recall Letter on June 19, 2017, to their customers via FedEx next day delivery service. Pursuant to the WARNINGS section of our CS100i, CS100 or CS300 IABP Operating/User Instructions, clinicians are instructed not to leave the patient unattended during IABP therapy. Until the service is performed, we recommend the IABP be powered on prior to initiation of therapy to allow the IABP to successfully complete its self-test. This action will take less than 60 seconds to perform. In the event the IABP fails to successfully complete the self-test and exhibits electrical test failure code 58, please remove the IABP from service and contact your local Maquet/Getinge Sales & Service Office. Customers will be instructed to complete and return the attached Medical Device Field Correction Response Form via fax to 1-973-807-9217 or send via email to IABP2017@getinge.com.ABP2017@getinge.com. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. For U.S. customers with technical questions, please contact our Technical Support Department (at 1-888-627-8383 and press 3), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST

Device

Device Recall CS 100i IntraAortic Balloon Pump

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