Events

PRIMEDIC™ AkuPak LITE 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 Metrax GmbH 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
  • 날짜
    2016-06-07
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • 데이터 추가 비고
  • 원인
    If the primedic™ defimonitor xd is stored for long periods with the primedic™ akupak lite inserted and with direct connection to the mains power via the integrated mains unit, the defibrillator is only supplied from this source in the course of the daily self-test, i.E. no power is taken from the battery inserted in the unit. this means that the battery management system (bms) integrated in the primedic™ akupak lite will not have its residual capacity checked by a new evaluation throughout the entire period. for this reason, internal power consumption and chemical self-discharge of the cells can result in a reduction in the capacity, without starting a charging process for the primedic™ akupak lite. a new evaluation of the residual capacity will only take place when the primedic™ defimonitor xd is disconnected from the mains and is switched on. .

Device

PRIMEDIC™ AkuPak LITE
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    Metrax GmbH

Manufacturer

Metrax GmbH