Events

IPAD Defib Pad, CU-CUA0512F (used with I-PAD NF 1200 Defibrillator) 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-2013-RN-00169-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2013-02-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00169-1
  • 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
    Discrepancy exists between the voice prompt of the i-pad nf 1200 defibrillator (version 7.0 only) and the physical pads currently supplied: a) the voice prompt says "remove the white and blue packet and tear open the package across the top and remove pads". please note the defibrillator pad packet supplied with the unit is white and orange, not white and blue. b) the voice prompt then says "... peel the pad completely from it's white backing".Please note that the backing is blue for some lot numbers supplied. note that both pads are compatible regardless of the backing colour.
  • 조치
    For problem a): In order to avoid any confusion during use of the I-PAD NF 1200 Defibrillator, Device Technologies is supplying blue labels that can be placed over the orange section of the current packet. This will ensure the packet colour matches the voice prompt. For problem b): Device technologies is advising that both pads are compatible regardless of the backing colour. Device Technologies will contact affceted customers when new pads are available to match the voice prompt.

Device

IPAD Defib Pad, CU-CUA0512F (used with I-PAD NF 1200 Defibrillator)

Manufacturer

Device Technologies Australia Pty Ltd