Events

Device Recall Maquet Cardiopulmonary Heater Cooler Unit HCU30 Type 2 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Maquet Cardiovascular Us Sales, Llc 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
    72652
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0589-2016
  • 사례 시작날짜
    2015-11-13
  • 사례 출판 날짜
    2016-01-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-04-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141824
  • 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
    Controller, temperature, cardiopulmonary bypass - Product Code DWC
  • 원인
    Failure of the heater-cooler unit (hcu 30) type 2 power supply board. a drop of more than 10% voltage can cause overheating and subsequent failing of the r56 thermistor of the power supply board. board failure typically occurs when the compressor is switched on (prior to patient use); however, it can occur during patient use. this can shut down the compressor or the entire hcu 30 type 2 unit.
  • 조치
    MAQUET sent "Product Recall Urgent Medical Device Field Correction" notices and "Medical Device Field Correction Response Forms" dated 11/13/2015 via UPS to affected customers. The notification identified the issue and how to identify the affected unit. The notification instructed customers to always keep a replacement heater-cooler unit on standby in the event of a unit failure; complete the attached Field Correction Response form (fax to 1.973.629.1518 or email to HCU30@maquet.com; and that they would be contacted by a representative of the Maquet Service Team to schedule an onsite service to determine if the power supply board in their HCU 30 Type 2 unit is affected adn replace the power supply board as necessary. If the customer had any questions they are instructed to contact their Maquet Service Representative or Maquet Technical Support at 1.888.627.8383 (Press option 3, followed by Option 1 and then option 1 again), Monday through Friday between the hours of 8:00 am and 5:00 pm.

Device

Device Recall Maquet Cardiopulmonary Heater Cooler Unit HCU30 Type 2
  • 모델명 / 제조번호(시리얼번호)
    HCU 30 Base Unit 100 - 120 V, Model Number 704629/70103.4371 HCU 30 Base Unit 200 - 240 V, Model Number 704631/70103.4642 HCU 30 Base Unit Canadian/US, Model Number 705501/70103.4653 Heater Cooler Unit 30 with Serial Number <93101480  The affected power supply boards have serial numbers less than 107006001.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    United States Nationwide Distribution
  • 제품 설명
    Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W || Product Usage: The Heater Cooler Unit (HCU) 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
  • Manufacturer
    Maquet Cardiovascular Us Sales, Llc

Manufacturer

Maquet Cardiovascular Us Sales, Llc
  • 제조사 주소
    Maquet Cardiovascular Us Sales, Llc, 45 Barbour Pond Drive, Wayne NJ 07470
  • 제조사 모회사 (2017)
    Getinge AB
  • Source
    USFDA