Events

Gel-E Donut, Squishon 2 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Philips Healthcare (Children’s Medical Ventures) 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/2014/038
  • 사례 연번
    CON459475
  • 날짜
    2014-09-30
  • 사례 출판 날짜
    2014-09-30
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON459475?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 infection, breathing difficulties and allergic reactions. philips healthcare (children’s medical ventures) has become aware of mould growth on these neonatal and paediatric support devices. the mould has been identified as cladosporium and penicillium fungi. the manufacturer sent a field safety notice (fsn) to customers in may 2014 but has not had sufficient confirmation that customers have received and acted on this notice.
  • 조치
    Identify affected devices as described in the FSN. Dispose of any product containing mould according to your local environmental guidelines. Fill in the customer reply form attached to the FSN and return it to your distributor.

Device

Gel-E Donut, Squishon 2
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 제품 설명
    Neonatal and paediatric support devices Gel-E Donut, part numbers: 92025-A, 92025-B, 92025-C Squishon 2, part number: 91033-2 All batches These are gel-filled products used in hospitals, under the supervision of a caregiver, to support and cradle an infant’s head and/or body. The part number is printed on the product itself.
  • Manufacturer
    Philips Healthcare (Children’s Medical Ventures)

Manufacturer

Philips Healthcare (Children’s Medical Ventures)
  • 제조사 모회사 (2017)
    Philips
  • Source
    MHRA