HeartStart MRx 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 Philips 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 국가
  • 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
    Philips has determined that there is a possibility of abnormal operation of the heartstart mrx monitor / defibrillator. in extremely rare cases, the following operating patterns may occur on the device: 1. if the pins with which the battery is attached to the device are damaged or dirty, the electrical connection may be poor. when the device is powered only by a battery, the device may not turn on or restart; 2. when the heartstart mrx monitor / defibrillator is disconnected from the power supply and a single battery is used as the sole power source, the following patterns of abnormal device operation may occur: a. when the user presses the charge button, the device attempts to charge, and after about 20 seconds, displays a "shock equipment malfunction" error message and is unable to perform shock treatment; b. the promotion may be interrupted without warning. these device performance patterns may occur until the unit is reset. both of these problems can cause a delay in monitoring or treatment.

Device

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    AMPMDRS