Events

Gas Bottle Holder HKH 8880 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Maquet Cardiopulmonary Ag 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
    79811
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1642-2018
  • 사례 시작날짜
    2018-04-04
  • 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=163499
  • 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
    Accessory equipment, cardiopulmonary bypass - Product Code KRI
  • 원인
    There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations.
  • 조치
    The Urgent Medical Device Recall Removal letter was distributed on 4/4/18. The letter instructed the customer to: Please examine your inventory for the affected 701050901 Gas Bottle Holder HKH 8880 and immediately remove it from use. Please contact your Getinge representative or call the Maquet/Getinge Customer Support at +1 (888) 627-8383 (press option 2, then option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone) to obtain instructions on returning the affected product for a full credit. Please complete and sign the attached MEDICAL DEVICE RECALL - RESPONSE FORM (page 3) to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to fieldactions@maquet.com or by faxing the form to +1 (973) 629-1655.

Device

Gas Bottle Holder HKH 8880
  • 모델명 / 제조번호(시리얼번호)
    US: 98880-020  Foreign: 98880 - 002, 98880 - 004, 98880 - 005, 98880 - 006, 98880-009, 98880-010, 98880-011, 98880-012, 98880- 013, 98880-014, 98880-016, 98880-017, 98880-018
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    The product was distributed to the following US state: MO. The product was distributed to the following foreign countries: France, Germany, Switzerland, and Thailand.
  • 제품 설명
    CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 || Product Usage: || The Cardiohelp Gas Bottle (or Cylinder) Holder HKH 8880 is an accessory for the CARDIOHELP System and required for inter-hospital patient transport in aircraft and road vehicles (mobile intensive care units and ambulances). Inter-hospital patient transport is transport of the patient between clinics, where the clinical environment is left (e.g., transport in vehicles such as ambulances or aircraft). The gas cylinder holder serves to hold an oxygen cylinder in aircraft.
  • Manufacturer
    Maquet Cardiopulmonary Ag

Manufacturer

Maquet Cardiopulmonary Ag
  • 제조사 주소
    Maquet Cardiopulmonary Ag, Kehler Strasse 31, Rastatt Germany
  • 제조사 모회사 (2017)
    Getinge AB
  • Source
    USFDA