Events

Device Recall Pulmonetic LTV Series Ventilator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Pulmonetic Systems, 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
    33974
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0185-06
  • 사례 시작날짜
    2005-11-09
  • 사례 출판 날짜
    2005-11-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-01-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42836
  • 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
    Pulmonetic systems has identified the potential of a printed circuit board malfunction, which can result in a ventilator malfunctio (e.G. vent inop, hw fault, xducer fault) and possibly resulting in failure of the ventilator to breathe for the patient. this malfunction may occur without an accompanying audible alarm.
  • 조치
    Urgent Medical Device Recall letter dated 11/09/05 is being sent via certified mail to affected customers. The letter informs customers of the issue. A Pulmonetic Systems representative will contact the customer within 72 hours to schedule a printed circuit board replacement. Customers are advised that in the interim all ventilator-dependent patients should be constantly monitored by qualified personnel to ensure that if a malfunction occurs, alternate ventilation can be provided.

Device

Device Recall Pulmonetic LTV Series Ventilator
  • 모델명 / 제조번호(시리얼번호)
    C01063, C01112, C01605, C02231, C02247, C02488, C03055, C03096, C03123, C03137, C03437, C03492, C03828, C03861, C03884, C04056, C04580, C05336, C06640, C07105-C07107, C07109-C07113, C07115, C07116, C07118, C07122-C07126, C07130, C07141, C07145, C07152, C07154, C07157-C07160, C07162, C07168, C07170, C07173, C07188, C07194 and C07195
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Within the US to AK, AZ, CA, CO, FL, GA, ID, IL, IN, LA, MI, MO, NE, NJ, NY, NV, OH, OK, OR, PA, SC, TX, UT, VA and WI. OUS to include: Belgium, Brazil, Canada, India, Italy, Korea and United Kingdom
  • 제품 설명
    Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-950. The LTV-950 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The LTV-950 is a prescription medical device suitable for use in institutional, home and transport settings.
  • Manufacturer
    Pulmonetic Systems, Inc.

Manufacturer

Pulmonetic Systems, Inc.
  • 제조사 주소
    Pulmonetic Systems, Inc., 17400 Medina Rd Ste 100, Minneapolis MN 55447-1341
  • Source
    USFDA