Events

MAQUET HCU 30 Base UnitHeater-Cooler Unit 30 with Serial Number < 93101480HCU 30 Base Unit 100 -120 V, article number 704629 / 70103.4371 HCU 30 base unit 200 -240 V, article number 704631 / 70103.4642 HCU 30 base unit Canadian/US, article number 705501 / 70103.4653 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Maquet 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-01088-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-11-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01088-1
  • 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
    Maquet cardiopulmonary has received complaints associated with a failure of the power supply board of the hcu 30. an internal investigation showed that a drop of more than 10% voltage can cause an overheating and subsequent failing of the ntc (negative temperature coefficient) r56 thermistor of the power supply board. an internal investigation showed that a drop of more than 10% voltage can cause an overheating and subsequent failing of the r56 thermistor of the power supply board of the hcu 30 type 2. a defective r 56 thermistor results in an inoperable compressor, the inability to actively cool the water or an inoperable hcu 30.There are no complaints reported associated with a patient injury or death.
  • 조치
    Users are asked to always keep a replacement unit on standby in order to ensure continuous operation in the event of a complete system failure, whilst the new power supply board which is equipped with a more robust NTC R56 thermistor is being installed. This action has been closed-out on 25/08/2016.

Device

MAQUET HCU 30 Base UnitHeater-Cooler Unit 30 with Serial Number < 93101480HCU 30 Base Unit 100 -1...
  • 모델명 / 제조번호(시리얼번호)
    MAQUET HCU 30 Base UnitHeater-Cooler Unit 30 with Serial Number < 93101480HCU 30 Base Unit 100 -120 V, article number 704629 / 70103.4371 HCU 30 base unit 200 -240 V, article number 704631 / 70103.4642 HCU 30 base unit Canadian/US, article number 705501 / 70103.4653ARTG Number: 144010
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd