Events

Esprit V1000 and Esprit/V200 Conversion VentilatorRespironics 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Philips Electronics Australia 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-2014-RN-01245-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-11-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01245-1
  • 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
    If the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (pcba) and short to ground which may prevent the ventilator to switch to battery power if ac power is disrupted. a high urgency audible alarm will sound alerting medical personnel of the loss of power. in the absence of ac power, failure of battery power will cause loss of ventilator support which could result in hypercarbia or hypoxemia.
  • 조치
    Philips is advising their customers to carry out a Power Fail Alarm Test as per the Operators Manual. If AC power is disrupted and the ventilator cannot switch to battery operation, a High Urgency alarm will sound and the patient must be supported with another means of life support ventilation. A new fan installation hardware kit will be installed on affected units. A Philips Field Service Engineer will be contacting customers to schedule the installation at no-cost. This action has been closed-out on 12/08/2016.

Device

Esprit V1000 and Esprit/V200 Conversion VentilatorRespironics
  • 모델명 / 제조번호(시리얼번호)
    Esprit V1000 and Esprit/V200 Conversion VentilatorRespironics Part Numbers: 701-01000-00, C701-01000-00, DU701-01000-00, U701-01000-00Philips Part numbers : 989805611721, 989805643301, 989805612621, 989805613441ARTG Number: 134845
  • 의료기기 분류등급
    Anesthesiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • 제조사 모회사 (2017)
    Philips
  • Source
    DHTGA