Events

HeartStart XL+ Defibrillator/Monitor 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
    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
    Through internal testing and customer complaint investigations, the following xl+ software and hardware issues have been identified: software: the xl+ may fail to complete the power on sequence and continuously reboot. the xl+ may either fail to power up or may shut down unexpectedly. the xl+ may have a software version that did not reset a fail-safe monitoring component which could delay of therapy or pacing interruption. the xl+ may fail to generate verbal prompts in aed mode. hardware: the xl+ may have been manufactured with a speaker that may fail. the battery may not seat properly causing the xl+ to shut down unexpectedly or remain powered on and not acknowledge or charge the battery. the xl+ exceeds the allowable radiated emissions level for class b cispr11. the xl+ ecg signal from leads could be lost and unrecoverable. the xl+ spo2 signal may lose communication and cause the device to reboot. the xl+ battery detection system may be disrupted and cause a false low battery alarm.

Device

HeartStart XL+ Defibrillator/Monitor
  • 모델명 / 제조번호(시리얼번호)
    USO1100100 to USD1101095, US11201096 to USD1203968, US11303969 to USD1309471, US11409472 to US61414022
  • Manufacturer
    Philips

Manufacturer

Philips
  • 제조사 모회사 (2017)
    Philips
  • Source
    AMPMDRS