Events

S74 Elite Sport Scooter with Leoch 20 amp/hour batteries 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Pride Mobility Products 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
    Safety alert / Field Safety Notice
  • 사례 ID
    MDA/2014/013
  • 사례 연번
    CON409261
  • 날짜
    2014-04-28
  • 사례 출판 날짜
    2014-04-28
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON409261?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 the scooter batteries overheating and swelling during the charging cycle.  this may result in a reduced range of travel or a failure of the scooter to drive as expected. pride mobility products ltd has identified that the overheating and swelling is caused by a manufacturing fault with the batteries. pride mobility products ltd issued a field safety notice in february 2014. however, it is not clear whether users have received and acted upon this information.
  • 조치
    Identify all users and staff responsible for users of S74 scooters and ensure that they receive the consumer letter attached to the manufacturer’s FSN. All users should contact their dealer for replacement batteries. Action by: All those involved in the provision, prescription and use of scooters.

Device

S74 Elite Sport Scooter with Leoch 20 amp/hour batteries
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    S74 Elite Sport Scooter with Leoch 20 amp/hour batteries Specific serial numbers. The following serial numbers are affected. SG211113017FVO – SG211113148FVO inclusive SG216713002FVO – SG216713169FVO inclusive SG219313286FVO – SG219313335FVO inclusive SG219313114FVO – SG219313211FVO inclusive
  • Manufacturer
    Pride Mobility Products Ltd

Manufacturer

Pride Mobility Products Ltd