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    平成31年 4月23日作成
    

    医療機器改修の概要

    (クラスII)

  1. 一般的名称及び販売名

  2. 一般的名称: パルスオキシメータ
    販売名  : (1)ベッドサイドSpO2モニタリングシステムJP (N-BSJP)
           (2)ベッドサイドSpO2モニタリングシステムJP (N-BSJ)
           (3)メインボード
    
    
  3. 対象ロット、数量及び出荷時期

  4. 品番:10005941JP
    名称:ベッドサイドSpO2モニタリングシステムJP (N-BSJP)
    対象ロット:2,103台
    出荷時期:2018年8月6日〜2019年3月4日
    シリアル番号:
    MBJ1810100 MBJ1810101 MBJ1810102 MBJ1810103 MBJ1810104
    MBJ1810105 MBJ1810106 MBJ1810107 MBJ1810108 MBJ1810109
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    MBJ1810130 MBJ1810131 MBJ1810132 MBJ1810133 MBJ1810134
    MBJ1810135 MBJ1810136 MBJ1810137 MBJ1810138 MBJ1810140
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    MBJ1810635 MBJ1810636 MBJ1810637 MBJ1810638 MBJ1810639
    MBJ1810640 MBJ1810641 MBJ1810642 MBJ1810643 MBJ1810644
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    MBJ1810650 MBJ1810651 MBJ1810652 MBJ1810653 MBJ1810654
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    MBJ1814442 MBJ1814443 MBJ1814444   
    
    品番:10005941JPN
    名称:ベッドサイドSpO2モニタリングシステムJP (N-BSJ)
    対象ロット:2,057台
    出荷時期:2018年8月27日〜2019年2月27日
    シリアル番号:
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    MBJ1814130 MBJ1814131     
    
    品番:10132593
    名称:メインボード
    対象ロット:207個
    出荷時期:2018年10月25日〜2019年2月27日
    シリアル番号:
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    BM18091536 BM18091537 BM18091538 BM18091539 BM18091540
    BM18091681 BM18091682 BM18091683 BM18091684 BM18091685
    BM18091686 BM18091687 BM18091688 BM18091689 BM18091690
    BM18091691 BM18091692 BM18091693 BM18091694 BM18091695
    BM18091698 BM18091716 BM18091721 BM18091722 BM18091723
    BM18091724 BM18091725 BM18091726 BM18091727 BM18091728
    BM18091729 BM18091730 BM18091733 BM18091734 BM18091735
    BM18091736 BM18091737 BM18091738 BM18091739 BM18091740
    BM18091840 BM18092087 BM18092136 BM18092187 BM18100173
    BM18120965 BM18120967 BM18120969 BM18120970 BM18120972
    BM18120973 BM18120983 BM18120985 BM18120986 BM18120987
    BM18120988 BM18120989 BM18120991 BM18120992 BM18120994
    BM18120995 BM18120996 BM18120997 BM18120998 BM18120999
    BM18121000 BM18121005 BM18121010 BM18121030 BM18121031
    BM18121033 BM18121037 BM18121039 BM18121201 BM18121204
    BM18121205 BM18121207 BM18121211 BM18121212 BM18121213
    BM18121214 BM18121215 BM18121216 BM18121217 BM18121218
    BM18121219 BM18121220 BM18121225 BM18121226 BM18121228
    BM18121229 BM18121230     
    
    
  5. 製造販売業者等名称

  6. 製造販売業者の名称 : コヴィディエン ジャパン株式会社
    製造販売業者の所在地: 東京都港区港南1丁目2番70号
    許可の種類     : 第一種医療機器製造販売業
    許可番号      : 13B1X00069
    海外製造業者:Mediana Co., Ltd.(メディアナ・カンパニー・リミッテド)大韓民国
    
    
  7. 改修理由

  8. 当該装置を使用中、「エラーEEE010」(センサもしくは装置内部の故障の一種))が発生した際に、「EEE010」
    という可視アラームはディスプレイ上に表示されますが、本来可視アラームと共に鳴動すべき可聴アラームが鳴
    動しない、という事例が報告されました。海外製造元で調査を実施した結果、特定のバーションのソフトウェア
    がインストールされた装置を使用し、センサもしくは装置内部の故障が生じた場合に、当該事象が発生すること
    が確認されました。このため、適正なソフトウェアをインストールする自主改修を実施することと致しました。
    
    
  9. 危惧される具体的な健康被害

  10. 当該事象のようなセンサもしくは装置内部の故障が発生した際は、ディスプレイには「---」が表示され、患者
    様のSpO2測定値、脈拍の測定値が表示されず、患者様の脈拍に同期したビープ音が発生しなくなることから、適
    正に測定されていないという異常を発見することができ、医療従事者による適切な対処が可能です。このため重
    篤な健康被害の発生には至らないと考えます。なおこれまでに当該事象による健康被害に関する報告は受けてお
    りません。
    
    
  11. 改修開始年月日

  12. 平成31年4月23日 情報提供の開始
    
    
    
  13. 効能・効果又は用途等

  14. 本品は、経皮的動脈血酸素飽和度(SpO2)及び脈拍数を連続的かつ非侵襲的にモニタリングするために用い
    られる。体動時及び安静時において、灌流の良好あるいは低灌流な新生児、小児及び成人の各患者に対して、
    病院、病院に準じた施設、院内搬送及び在宅ケアにおいて、医師の管理下でのみ使用される。
    
    
  15. その他

  16. 当該製品の納入先はすべて把握しておりますので、該当する代理店及び医療機関に対して情報提供の上、
    改修を実施致します。
    
    
  17. 担当者及び連絡先

  18. 担当者 : 塩田 公紀、山下 雅文
          コヴィディエンジャパン株式会社 品質改善部
    連絡先 :
          03-6776-0009
    電話番号:
          03-6774-4680