Events

Device Recall Cardiosave 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
    76052
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1386-2017
  • 사례 시작날짜
    2016-12-23
  • 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=152101
  • 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
    Maquet has received 3 confirmed complaints related to the li-lon battery used with the maquet cardiosave hybrid iabp and maquet cardiosave rescue iabp of the battery venting after being accidentally dropped.
  • 조치
    Maquet contacted their customers via letter on 12/23/16 and additional customers identified were notified on 1/10/17 and issued a recall letter/return response form. The letter identified the affected product problem and actions to be taken. Customers were instructed to complete and return the response form via fax to 1-973-629-1518 or email to cardiosavebattery@getinge.com

Device

Device Recall Cardiosave
  • 모델명 / 제조번호(시리얼번호)
    part number 0146-00-0097
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide
  • 제품 설명
    CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX || Li-Ion Battery affected part number is 0146-00-0097 || Product Usage: || The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons
  • 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