Events

Device Recall Pulmonetic System Universal Cable Adaptor for use on LTV Series Ventilator, Model 800 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
    30514
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0274-05
  • 사례 시작날짜
    2004-11-19
  • 사례 출판 날짜
    2004-12-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2005-12-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36027
  • 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
    Continuous, Ventilator, Home Use - Product Code NOU
  • 원인
    Reports have been received indicating that the universal cable adaptor, intended to correct an earlier class i recall of ltv series ventilators due to their inability to continue operating when external power source is switched to internal battery, is not functioning as intended and/or the cable is not securely attaching to the connection on the ventilator.
  • 조치
    Beginning November 19, 2004 consignees who received the Universal Cable Adaptors (UCA) as correction to the voluntary November 1, 2004 Class I Recall were notified by telephone to discontinue installation of adaptors in stock. A Universal Cable Adaptor Recall Notification will be distributed by Certified Mail on or about November 30, 2004 providing instruction to remove the UCA and instruct consignees to follow November 1, 2004 recall interim instructions. Additionally, all consignees will receive instructions (on December 7, 2004) on how to return any device affected by the November 1, 2004 Recall for a power board replacement at a Pulmonetic systems, Inc. authorized service center.

Device

Device Recall Pulmonetic System Universal Cable Adaptor for use on LTV Series Ventilator, Model...
  • 모델명 / 제조번호(시리얼번호)
    all Universal Cable Adapters identified on outer packaging as part no. 17820-001 and distributed between 11/02/04 and 11/08/04.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    throughout the United States and to countries such as Germany, Canada, United Kingdom, Australia and Japan
  • 제품 설명
    Universal Cable Adaptor (Part #17765-001 and labeled on outer package as part no. 17820-001) distributed for Field Installation on certain LTV series Ventilator, Model 800 with either part # 10134 or 11511 power boards affected by the Pulmonetic Systems, Inc., November 1, 2004 Class I recall (FDA Z-1485-04).
  • Manufacturer
    Pulmonetic Systems, Inc.

Manufacturer

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