Events

Acrobat Swing (AC Swing) arm 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Ondal 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 연번
    MDA/2013/020
  • 날짜
    2013-03-27
  • 사례 출판 날짜
    2014-12-17
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-acrobat-swing-ac-swing-arm-risk-of-injury-from-detachment-of-the-swing-arm
  • 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
    Risk of injury from detachment of the swing arm.After approximately seven years of use, the plastic spigot joint of the swing arm can fail through fatigue.Ondal issued a Field Safety Notice (61Kb) in December 2012 to the suppliers that use these swing arms. Users should have been informed of this by their respective equipment supplier.
  • 원인
    (ondal) after approximately 7 years of use, the plastic spigot joint of swing arm can fail through fatigue. (mda/2013/020).
  • 조치
    Identify all Ondal swing arms fitted with a plastic spigot.Contact the supplier of the equipment to arrange for them to replace affected swing arms.Users are advised to move lights and monitors carefully until affected swing arms are replaced.

Device

Acrobat Swing (AC Swing) arm
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Acrobat Swing (AC Swing) arm. Manufactured by Ondal.Supplied by various companies to support operating lights and monitors.Delivered from 1999 to 2008 inclusive.Identifying affected devices:The Ondal AC Swing arm may be curved or straight.Curved arms will usually have a plastic spigot joint, which needs to be changed. Some may have a metal spigot joint, which is not affected.Straight arms usually have a metal spigot joint, which is not affected.  However, all straight arms should be checked to confirm that this is the case.Suppliers may have added their name to the product and issued their own Field Safety Notices (FSN) on this issue. Advice includes removing the plastic cap on top of the spigot joint, held in place by a cross-head screw. If the spigot is plastic, contact the supplier of the equipment to arrange for them to replace the affected swing arm.The affected Ondal AC Swing spring arms are widely used in the UK. Suppliers include (but are not limited to) the following: Trumpf Brandon Draeger Martin Merivaara
  • Manufacturer
    Ondal

Manufacturer

Ondal
  • 제조사 주소
    Contact the company that supplied you with the swing arm.Known suppliers are: Trumpf Name: Alasdair Owen Telephone number: 01582 399 201 Brandon Name: Mandy Pearson Telephone number: 0113 272 8844 Draeger Name: Doug Sims Telephone number: 01442 292 868 Martin Name: Dr Ingo Haas Telephone number: 00 49 7463 838 185 Merivaara Name: Esko Hyvarinen Telephone number: 00 358 333 94 6186Note: this is not an exhaustive list of suppliers.
  • 제조사 모회사 (2017)
    Orlando Luxembourg Investments Sarl
  • Source
    MHRA