Events

TCM CombiM module (used with Radiometer Transcutaneous Monitors) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Radiometer Pacific 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-01200-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-12-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01200-1
  • 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
    Radiometer has recently become aware that tcm combi m modules with a serial number below 903-111r0174nxxx* may, on rare occasions, have an error that will cause the alarm sound to be higher than the pre-set maximum volume.If the alarm sound is higher than the pre-set volume then critically ill premature infants may experience a critical stress reaction if the tcm combi m monitor is placed close to the infant and the too high alarm is not silenced.
  • 조치
    Radiometer is advising users with devices in Newborn or NICU units to turn off the monitor and contact Radiometer if the error occurs. Radiometer will be replacing all units which are used in these areas. Radiometer is providing a warning label to be placed on all TCM4 units which are not used in the Newborn or NICU units, and to advise Radiometer if the error occurs. This action has been closed-out on 31/08/2016.

Device

TCM CombiM module (used with Radiometer Transcutaneous Monitors)
  • 모델명 / 제조번호(시리얼번호)
    TCM CombiM module (used with Radiometer Transcutaneous Monitors)Product Code: 903-111Affected Serial Numbers: below 903-111R0174Nxxx ARTG Number:167226
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd