Events

Device Recall Newport HT50 Ventilator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Newport Medical Instruments Inc 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
    58629
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2382-2011
  • 사례 시작날짜
    2010-05-14
  • 사례 출판 날짜
    2011-05-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-06-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99738
  • 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
    Ventilator continuous facility use - Product Code CBK
  • 원인
    The recall was initiated because newport medical has confirmed that the newport ht50 hard shell emergency preparedness (ep) storage cases must be relabeled to caution users to follow current labeling guidelines for charging the battery for 8 hours but not longer than 24 hours at any one time.
  • 조치
    Newport Medical sent an FIELD CORRECTION NOTICE to all affected customers dated May 14, 2010. The letter identified the product, the problem and the action needed to be taken by the customer. Newport Medical also provided a revised labeling for the Emergency Preparedness (EP) Storage Case and an instruction sheet describing where to apply the new labels. Customers were instructed with the information that all the EP storage cases must be relabeled to caution users to follow current labeling guidelines for charging the battery for 8 hours but not longer than 24 hours at any one time. Customers were instructed to complete the attached acknowledgement form and fax it to " Regulatory@NewportMedical.com " Customers with any questions should call Technical Support Department at (800) 451-3111 for US customers, and (714)427-5811 x500 for international customers.

Device

Device Recall Newport HT50 Ventilator
  • 모델명 / 제조번호(시리얼번호)
    EP Cases are not serialized and are not always associated with a specific ventilator serial number. The field correction applies to all Emergency Preparedness (EP) Storage Cases used to store HT 50 ventilators.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA including states of PA, TX, AK, GA, CA, MD, KY, FL, VA, LA, NC, OK and countries of Canada, Colombia, Armenia and Japan.
  • 제품 설명
    Newport HT50 Ventilator. || Model No. HT50-H, HT50-HB, HT50-H1, and HT50-H1B. || The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 Ibs)
  • Manufacturer
    Newport Medical Instruments Inc

Manufacturer

Newport Medical Instruments Inc
  • 제조사 주소
    Newport Medical Instruments Inc, 1620 Sunflower Ave, Costa Mesa CA 92626-1513
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA