Events

Cervical Halo Traction Apparatus 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 Jerome Medical 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 연번
    SN2004(02)
  • 날짜
    2004-03-12
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/cervical-halo-traction-apparatus&id=8895f825-9782-6eee-9b55-ff00008c97d0
  • 비고 / 경고
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • 데이터 추가 비고
  • 원인
    The potential for imaging problems ranging from artifact, sparking, vibration, patient discomfort and / or surface burns when the cervical halo device is worn during a mri scan.
  • 조치
    Ensure that all devices that are sold as single use devices are only use once Ensure that MRI compatible devices are configured and positioned in the MRI so as to ensure that they are not too close to the MRI core and that metal components are not  criss-crossing or concentrated in one area  Ensure that the use of all MRI compatible devices are reviewed when any changes are made to the MRI strength to ensure that they still remain compatible  Ensure that patients screening forms are completed for all patients. (see form attached checklist) Report any indications of problems to the IMB

Device

Cervical Halo Traction Apparatus
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Cervical Halo Traction Apparatus
  • Manufacturer
    Jerome Medical

Manufacturer

Jerome Medical