Events

SleepStyle CPAP devices 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Fisher & Paykel Healthcare 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
    Safety alert / Field Safety Notice
  • 사례 ID
    MDA/2010/076
  • 사례 연번
    CON094175
  • 날짜
    2010-09-29
  • 사례 출판 날짜
    2010-09-29
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON094175?tabName=allTabs
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • 데이터 추가 비고
  • 원인
    Risk of cessation of therapy due to deterioration of power cord.Fisher & paykel healthcare has received reports of deterioration in the connectors of power cords supplied with their cpap flow generators.A power cord that deteriorates will stop working because of a disconnection in the internal wiring, which may lead to arcing and ultimately could cause a melt or breach of the outer cord sheath (insulation); this may arise near the connector that plugs into the cpap unit.
  • 조치
    Ensure that all users, including patients at home, are aware of the manufacturer’s Field Safety Notice. Identify affected devices. The model number and lot number are located on the bottom of the CPAP device. Remove the water chamber or empty it before viewing the bottom of the device. Contact the manufacturer to arrange for a replacement power cord. In the interim users should continue with their CPAP therapy.

Device

SleepStyle CPAP devices
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    SleepStyle CPAP devices. Manufactured by Fisher & Paykel Healthcare. Specific model and lot numbers are affected. This device is used for the treatment of obstructive sleep apnoea and delivers continuous positive airway pressure (CPAP) to assist with a patient’s breathing during sleep. The device is for use by adult patients at home or in a sleep laboratory. The model numbers of affected devices are: HC23XAEK and HC23XMEK HC24XAEK and HC24XMEK HC254AEK and HC254MEK HC60XAEK and HC60XMEK (Where X is a number). The relevant LOT numbers are those up to and including 091122. The image below shows where the model and lot number are located on the device label. CPAPs manufactured with lot numbers higher than 091122 have a different power cord and are not subject to this product replacement.
  • Manufacturer
    Fisher & Paykel Healthcare

Manufacturer

Fisher & Paykel Healthcare