Events

translation missing: ko.activerecord.attributes.event.titles.recall_field_safety_notice

Saudi Food & Drug Authority에 따르면, 해당 translation missing: ko.activerecord.attributes.event.types.recall_field_safety_notice 는 Saudi Arabia 에서 B Braun Medical Inc. 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
    Recall / Field Safety Notice
  • 사례 ID
    mdprc 112 09 18 000
  • 사례 시작날짜
    2018-09-26
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13222
  • 비고 / 경고
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • 데이터 추가 비고
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    In the course of post market surveillance activities we discovered that the above specified power cords might get damaged at the device connector. in very rare cases, the device connector might break if heavy lateral force is applied (see figure 1). if exposed electrical contacts are touched the user might be opposed to the potential risk of an electrical shock.

Device

220-240V Unit Cable (power cord) for Infusomat fmS, Infusomat P and SpaceCover
  • 모델명 / 제조번호(시리얼번호)
    Affected power cords have been manufactured by B Braun supplier HAWA in the period from July 2016 (marked as M7 Y6) until June 2018 (marked as M6 Y8). The affected power cord has been shipped together with one of the following products: Infusomat P Deutsch 230 V (8712174), Infusomat P Netherlands 230 V (8712190), Infusomat P Czech 230 V (8712344), Infusomat P English 230 V (8712379), SpaceCover Comfort (8713145), SpaceCover Standard (8713147), Infusomat fmS Deutsch 230 V (8715424), Infusomat fmS Danish 230 V (8715432), Infusomat fmS Spanish 230 V (8715459), Infusomat fmS French 230 V (8715521), Infusomat fmS English 230 V (8715548), Infusomat fmS Italian 230 V (8715564), Infusomat fmS Czech 230 V (8715580) and as separate 220-240V Unit Cable (34502718).
  • 제품 설명
    Infusion pumps, power cord
  • Manufacturer
    B Braun Medical Inc.

Manufacturer

B Braun Medical Inc.