Events

Rainbow Reusable Sensors for rainbow SET Devices with SpCO, SpO2, and SpMet. (used with pulse oximeter for the measurement of parameters such as arterial oxygen). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Masimo 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-01074-1
  • 사례 위험등급
    Class II
  • 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-01074-1
  • 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
    Masimo has identified specific lots of sensors that were manufactured with incompatible configurations. this could result in sensors that will either not provide readings for the spco and spmet parameters or inaccurate readings. the specific behaviour will depend on the firmware version of the technology board in the device. spco measurements, when displayed, could be incorrectly elevated throughout the measurement range. spmet measurements above 6% could be affected by a negative bias of 1.5%, on average.
  • 조치
    Masimo is advising users to inspect stock and quarantine any affected units for replacement with unaffected stock. This action has been closed-out on 18/08/2016.

Device

Rainbow Reusable Sensors for rainbow SET Devices with SpCO, SpO2, and SpMet. (used with pulse oxi...
  • 모델명 / 제조번호(시리얼번호)
    Rainbow Reusable Sensors for rainbow SET Devices with SpCO, SpO2, and SpMet. (used with pulse oximeter for the measurement of parameters such as arterial oxygen). Reference: 2696 Lot Number: 15HA6Sensor Reference: 24087-A15G760 , 24087-A15H754ARTG Number: 157503
  • Manufacturer
    Masimo Australia Pty Ltd

Manufacturer

Masimo Australia Pty Ltd