Events

Contoura 880 Beds 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 Huntleigh Healthcare Ltd 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
    2009-08-21
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/contoura-880-beds&id=de8cf825-9782-6eee-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
    Some bed rail support brackets have been found to have poor welds causing them to fail in use. patients are at risk of injury from a fall if the bed rails fail in use.
  • 조치
    1) Ensure the appropriate personnel are made aware of this notice.  2) Identify the location of all Contoura 880 beds.  3) Determine if your institution has devices affected by this issue.  This can be determined by:       A) Checking the manufacturing date to see if it is between December 1999 and June 2001.       B) Checking if the Serial number lies in the range 167386 to 382938.  4) Check the support bracket on the frame and if cracking is found contact the manufacturer who will provide and fit replacement brackets free of charge.  5) Ensure that correction is completed on all affected devices.

Device

Contoura 880 Beds

Manufacturer

Huntleigh Healthcare Ltd