平成21年5月19日作成

一般的名称：成人用人工呼吸器
販売名　　：ニューポート ベンチレータ モデルe360

対象品名　　：E360E（カタログ番号）
対象製造番号：
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N09360413906

出荷数量：638台
出荷時期：平成19年3月19日〜平成21年5月7日

製造販売業者の名称　：株式会社 佐多商会
製造販売業者の所在地：東京都品川区勝島1‐5‐21　東神ビル内
業許可の種類　　　　：第一種医療機器製造販売業
業許可番号　　　　　：13B1X00074

　輸入先製造業者より、ソフトウェアのアップグレード改修を行うとして以下の連絡がありました。これに
基づき、自主改修を行うことといたしました。

　装置が作動中に分時換気量警報やバックアップ換気警報等が頻発した場合、換気動作は停止せず換気警報
も正常に動作しているが、「装置警告」警報ランプが点灯して断続的な警報音が鳴り、消音できないとの報
告を受けました。調査の結果、換気動作が停止していない時に発生する断続的な警報音の「装置警告」は、
誤警報であることが分かりました。
　なお、この誤警報の調査の際、理論上発生が考えられる様々な「装置警告」警報の動作を検証した結果、
これまで報告は受けておりませんが、「装置警告」警報が正常に動作した時にモニタ画面や「装置警告」警
報ランプの点灯は保持されるものの連続的な警報音が途中で消音する可能性があることが分かりました。

　「装置警告」の誤警報が発生する時には人工呼吸器の換気動作は停止せずに換気警報も正常に動作します
ので、患者様の安全性には影響は無く、医療従事者が適切な対応を取ることで重篤な健康被害につながる可
能性は無いと考えます。
　なお、連続的な警報音の途中消音に関しては、モニタ画面や警報ランプの点灯は保持されるので医療従事
者が気付くことができ、また添付文書および取扱説明書に記載されている警報機能付き患者モニタの併用に
より医療従事者が患者様の状態を監視して適切な対応を取ることができますので、重篤な健康被害の可能性
は低く、回避可能と考えております。
　上記改修理由となった問題について、これまで国内外を通じて健康被害の報告は受けておりません。

　　平成21年5月14日（情報提供開始日）

　　本装置は幼児、小児及び成人を対象とした人工呼吸器です。

　納入いたしました医療機関等は全て把握しておりますので、文書による通知を行うと共に改修作業を実施
いたします。

　　連絡先：株式会社 佐多商会
　　　　　　東京都品川区勝島1‐5‐21　東神倉庫内 技術センター
　　　　　　電話番号　03-5762-3077
　　　　　　FAX番号　 03-5762-3036
　　担当者：安全管理業務室　柴田連右