Events

Zoll AED Plus Defibrillator 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 Zoll Medical Corporation 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 사례 연번
    SN2009(13) Updated Version
  • 날짜
    2011-05-23
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/zoll-aed-plus-defibrillator&id=6e86f825-9782-6eee-9b55-ff00008c97d0
  • 비고 / 경고
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • 데이터 추가 비고
  • 원인
    The zoll aed plus defibrillator may not deliver therapy.
  • 조치
    1. Ensure that the relevant personnel in your organisation are made aware of this  issue.  2. Determine if you have purchased the affected serial numbers of this product,  AED Plus devices with serial numbers below X_ _ _200000.  3. If you have an affected device confirm that the recommended actions have been completed:  Ensure that the date when the batteries were installed in your device has been checked.  a. If batteries were installed more than three (3) years ago, replace the batteries  as soon as possible and add the label provided by Zoll showing the next  scheduled replacement date. Read and add the addendum incorporating this  information to the administrator’s guide that was provided by Zoll.  b. If batteries are not more than three (3) years old, add the label provided by  Zoll completed with the next scheduled replacement date. Read and add the  addendum, provided by Zoll, incorporating this information to the  administrator’s guide.

Device

Zoll AED Plus Defibrillator

Manufacturer

Zoll Medical Corporation