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neoBLUE® blanket system performance 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 Natus Medical Incorporated 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
    2016-10-12
  • 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
    The neoblue blanket system you received included the reliability update to prevent the potential early degradation and melting of the fiberoptic bundle at the pad connection to the neoblue blanket light box. this reliability update was intended to prevent the previous discoloration and melting, and natus wants to ensure that you do not experience any further issues. .

Device

neoBLUE® blanket system performance
  • 모델명 / 제조번호(시리얼번호)
    006244 neoBLUE blanket LED Phototherapy System with Large blanket/pad; US power cord 006895 neoBLUE blanket LED Phototherapy System with Small blanket/pad; US power cord 007299 neoBLUE blanket LED Phototherapy System with Large blanket/pad; EU power cord 007300 neoBLUE blanket LED Phototherapy System with Small blanket/pad; EU power cord 007296 neoBLUE blanket LED Phototherapy System with Large blanket/pad; UK power cord 007298 neoBLUE blanket LED Phototherapy System with Small blanket/pad; UK power cord 007301 neoBLUE blanket LED Phototherapy System with Large blanket/pad; AUS power cord 007302 neoBLUE blanket LED Phototherapy System with Small blanket/pad; AUS power cord
  • Manufacturer
    Natus Medical Incorporated

Manufacturer

Natus Medical Incorporated