BariAir Therapy System (Provides low air-loss pressure management therapy, pulsation, percussion, turn-assist, flexible patient positioning capabilities and built-in scales for large patients) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 ARJO Hospital Equipment Pty Limited 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
    RC-2013-RN-00398-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-05-03
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    There have been reports of patients inadvertently placing the system into a pseudo-exit position when using the hand control pendant.
  • 조치
    Customers are requested to remove the hand pendant from use on all BariAir Therapy Systems. If removal of the hand pendant is not possible it is recommended that patient positioning is regularly inspected. A new hand pendant has been developed. ArjoHuntleigh will contact their customers to coordinate the replacement of the hand pendant.

Device

  • 모델명 / 제조번호(시리얼번호)
    BariAir Therapy System (Provides low air-loss pressure management therapy, pulsation, percussion, turn-assist, flexible patient positioning capabilities and built-in scales for large patients)Model Number: 404000Affected Serial Numbers: BKIK00570, BKIK00565 and BKIK00563Supplied previously in Australia by KCI Medical Australia Pty Ltd under ARTG# 176118
  • Manufacturer

Manufacturer