Invacare PerfectO2 Oxygen Concentrator (Provides supplemental oxygen to patients with respiratory disorders) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Invacare Australia Pty Ltd 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-2015-RN-00075-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-02-06
  • 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
    Invacare has become aware of five reported instances in the european union in which the capacitor, an internal electrical component of the concentrator, ruptured which results in a potential fire hazard. invacare has learned that the psi (pressure sensitive interrupter) design for the compressor motor start/run capacitor (an internal electrical component of the concentrator) by one supplier could lead to rupture. the capacitor in the oxygen concentrator has an internal pressure relief component (the psi) which may not operate as intended permitting the capacitor to rupture in certain circumstances. if the psi does not function to relieve the heat and pressure due to a short circuit within the capacitor, then the pressure can cause a rupture in the seam between the housing and the end plate. if the rupture occurs, the oil may be expelled from the capacitor which may result in a fire hazard. there were no injuries reported in any of the five instances.
  • 조치
    Invacare is requesting customers to: 1. Examine their stock and quarantine any affected concentrator(s) 2. Inspect each impacted concentrator and if it contains a Dianz capacitor with date codes from 2010.03.XD (March, 2010) to 2012.08.XD (August, 2012) replace the capacitor using the recall replacement kit(s) 1131250 provided to the customer at no charge. 3. Upon completing the correction, quarantine and destroy all impacted capacitors. This action has been closed-out on 26/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    Invacare PerfectO2 Oxygen Concentrator (Provides supplemental oxygen to patients with respiratory disorders)Model Numbers: IRC5PO2VAW, IRC5PO2AWSerial Numbers Range: 10CSZ43XXXX - 12GSZ62XXXXManufactured between March 2010 to August 2012 Dianz capacitor date codes 2010.03. XD to 2012.08.XD ARTG Number: 144033
  • 의료기기 분류등급
  • Manufacturer

Manufacturer