Events

PS900 Power Module supplied with 12 Lead ECG Interp. 210mm Basic Monitors 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Device Technologies 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-2016-RN-00040-2
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2016-01-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00040-2
  • 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
    A quality issue has been identified, relating to an incorrect power status indication with the ps900 power module supplied with the affected patient monitoring products. the products with the defective power module installed can generate false "battery low" alarms, and may have an incorrect power status shown on the screen.The battery cannot be used in its current state as it cannot be recharged. however, the products can continue to be used the by plugging them into main power.
  • 조치
    The sponsor is advising users that the affected devices can continue to be used provided that they are connected to a main power. The sponsor will contact the affected users to arrange for a firmware upgrade and/or the replacement of the power module. This action has been closed-out on 16/05/2017.

Device

PS900 Power Module supplied with 12 Lead ECG Interp. 210mm Basic Monitors
  • 모델명 / 제조번호(시리얼번호)
    PS900 Power Module supplied with 12 Lead ECG Interp. 210mm Basic Monitors Product code: ED-SE-1200E-BSerial numbers of the monitors affected:60531-M1590102000160531-M1590102000260531-M1590102000360531-M1590102000560531-M1590102000960531-M1590454000260531-M1590454000311076-M1590453000111076-M1590453000211076-M1590453000311076-M1590453000411076-M15904530005ARTG Numbers: 178086 and 236697
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd