Events

Rotoprone Therapy System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 ArjoHuntleigh 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
    67248
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0926-2014
  • 사례 시작날짜
    2013-09-11
  • 사례 출판 날짜
    2014-02-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-01-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125084
  • 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
    Bed, patient rotation, powered - Product Code IKZ
  • 원인
    The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient.
  • 조치
    ArjoHuntleigh Inc. sent a Technical Bulletin package to all affected service centers and an Urgent Field Safety Notice package to all affected customers. For rental units, a training plan was established for employees. For sold units, the notice contain a revised user manual and label explaining what to do if the lock pin becomes stuck in the "in" position. Customers that purchased the affected product were required to complete and return a Customer Response form to ArjoHuntleigh to confirm receipt and understanding of the field safety notice, and that the required actions were completed. For questions call 630-785-4885.

Device

Rotoprone Therapy System
  • 모델명 / 제조번호(시리얼번호)
    Model #209500
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide and Middle East
  • 제품 설명
    The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning. || Product Usage: Use of the Rotoprone Therapy System is indicated for patients with severe acute respiratory distress syndrome (ARDS). These are critical patients who are at higher risk of cardiac arrest and mortality. Placing a patient in the prone position may reopen collapsed airways and thus improve pulmonary gas exchange and respiratory mechanics.
  • Manufacturer
    ArjoHuntleigh Inc.

Manufacturer

ArjoHuntleigh Inc.
  • 제조사 주소
    ArjoHuntleigh Inc., 4958 Stout Dr, San Antonio TX 78219-4334
  • 제조사 모회사 (2017)
    Getinge AB
  • Source
    USFDA