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平成29年 1月24日作成 平成29年 3月13日訂正(*)
一般名及び販売名
一般的名称: パルスオキシメータ 販売名 : ベッドサイドSpO2モニタリングシステムJP
対象ロット、数量及び出荷時期(*)
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製造販売業者等名称
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(韓国)
改修理由
当該装置を使用中に本体正面のディスプレイに表示されているSpO2, 脈拍等がフリーズした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、WiFi通信が途絶えた状況が長時間継続された状態で使用された場合、当該事 象が発生することが確認されました。 このため、当該事象に対応した修正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。
危惧される具体的な健康被害
本体正面のディスプレイが適切に表示されなくなり、SpO2, 脈拍等に関し設定したアラームが鳴動しなくなる可 能性がありますが、当事例はWiFi通信障害の条件下において発生し、WiFi通信に障害が発生した際は通信障害の アラームが鳴動することから、医療従事者による適切な対処が可能であり、重篤な健康被害を招く可能性はあり ません。 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。
改修開始年月日
平成29年1月24日 (情報提供の開始)
効能・効果又は用途等
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。
その他
当該製品の出荷先はすべて把握しておりますので、連絡の上、改修を実施致します。
担当者及び連絡先
担当者 : 品質改善部 塩田 公紀 山下 雅文 連絡先 : コヴィディエンジャパン株式会社 電話番号: 03-6776-0009