Events

Samaritan PAD 500P (Public Access Defibrillator) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Aero Healthcare 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-2014-RN-00243-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-03-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00243-1
  • 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
    The software in the affected samaritan® pad 500p may miscalculate the cpr rate of compression per minute being administered to the patient. the rescuer may, therefore, be incorrectly advised by the device to “push slower” when, in fact, the cpr rate is at an acceptable level.
  • 조치
    Aero Healthcare is advising users not to remove devices from service. Aero Healthcare is advising users that to address the issue an updated software version is available on the HeartSine Technologies website for download. Please follow the instructions provided by Aero Healthcare to download the new software. Alternatively, Aero Healthcare can provide an upgrade kit which includes a CD with the updated software version.

Device

Samaritan PAD 500P (Public Access Defibrillator)
  • 모델명 / 제조번호(시리얼번호)
    Samaritan PAD 500P (Public Access Defibrillator) Serial Numbers: 10B0010001 to 14B00461703Manufactured between February 2010 and January 2014ARTG Number: 156690
  • Manufacturer
    Aero Healthcare

Manufacturer

Aero Healthcare