Events

Philips HeartStart MRx Defibrillator/MonitorMRx unit types with software versions F.03.06 (M3535A) and T.00.05 (M3536A) and earlier 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-2015-RN-01079-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-11-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01079-1
  • 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
    Mrx model m3535a and model m3536a may stop the automated ready-for-use (rfu) test in an abnormal state when the device is turned off. if this occurs, the rfu indicator window displays a pattern that is not documented in the instructions for use (ifu) or service manual. if this pattern appears and the device is turned on, it will revert the rfu back to an hourglass, indication that it is fully functional in all monitoring and therapy modes. there is no clinical risk if the device that has displayed this rfu pattern is turned on and put into service. a device experiencing this issue will continue to run automated rfu test hourly and report a 0x00c000a4 code in the status log summary each time.
  • 조치
    All MRx users should be informed that if the pattern appears, they can continue to use the device. Once the MRx is turned on, the pattern will disappear and the device will function normally in all monitoring and therapy modes. Philips will provide a software upgrade – for M3535A (software version F.03.07 or higher) and M3536A (software version T.00.06 or higher) – to correct this issue. A software upgrade will be provided free of charge for all affected products. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrades.

Device

Philips HeartStart MRx Defibrillator/MonitorMRx unit types with software versions F.03.06 (M3535A...
  • 모델명 / 제조번호(시리얼번호)
    Philips HeartStart MRx Defibrillator/MonitorMRx unit types with software versions F.03.06 (M3535A) and T.00.05 (M3536A) and earlier Part Numbers: M3535A, M3535ATZ, M3536A, M3536ATZ, M3536J, M3536M, M3536M2, M3536M4, M3536M5, M3536M6, M3536MCARTG Number: 261352
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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