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平成29年 4月11日作成
一般名及び販売名
一般的名称： 汎用人工呼吸器 販売名 ： (1)ニューポートベンチレータモデルHT70 (2)ニューポートベンチレータモデルHT70プラス
対象ロット、数量及び出荷時期
対象製品番号 : HT70, HT70P 対象ロット番号： 10HT700710132 10HT700710133 10HT700710134 10HT700710135 10HT700710136 10HT700710156 10HT700710157 10HT700710158 10HT700710159 10HT700710160 10HT700710161 10HT700710162 10HT700710163 10HT700710164 10HT700710165 10HT700810192 10HT700810193 10HT700810194 10HT700810195 10HT700810196 10HT700810197 10HT700810198 10HT700810199 10HT700810200 10HT700810201 10HT700810202 10HT700810203 10HT700810204 10HT700810205 10HT700810206 10HT700910223 10HT700910226 10HT700910227 10HT700910255 10HT700910256 10HT700910257 10HT700910258 10HT700910259 10HT700910260 10HT700910261 10HT700910262 10HT700910263 10HT700910264 10HT700910265 10HT700910266 10HT700910267 10HT701010279 10HT701011004 10HT701011014 10HT701011015 10HT701011016 10HT701011017 10HT701011018 10HT701111019 10HT701111020 10HT701111043 10HT701111044 10HT701111045 10HT701111048 10HT701111049 10HT701111050 10HT701111051 10HT701211064 10HT701211065 10HT701211066 11HT700111137 11HT700111138 11HT700111139 11HT700111140 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N15720716788 N15720716789 N15720716790 N15720716791 N15720716871 N15720716872 N15720716873 N15720716874 N15720716875 N15720716876 N15720716877 N15720716878 N15720716879 N15720716880 N15720716881 N15720716882 N15720716883 N15720716884 N15720716885 N15720716886 N15720716887 N15720716888 N15720716889 N15720716890 N15720716891 N15720716892 N15720716893 N15720716894 N15720716895 N15720716896 N15720718408 N15720718409 N15720718410 N15720718411 N15720718412 N15720816908 N15720816909 N15720816910 N15720816911 N15721018687 N15721018688 N15721018689 N15721018690 N15721018691 N15721018692 N15721018693 N15721018694 N15721018695 N15721018696 N15721018697 N15721018698 N15721018699 N15721018700 N15721018701 N15721018702 N15721018704 N15721018705 N15721018707 N16720219153 N16720219154 N16720219155 数量：1,577台 出荷時期：平成22年8月24日〜平成28年12月22日
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 ： Covidien(アメリカ合衆国）
改修理由
ニューポートベンチレータモデルHT70、ニューポートベンチレータモデルHT70プラスをご使用の際、換気動作 中、当該装置がアラームを鳴動せずリセットが発生したという事例が報告されました。 その後海外製造元にて 調査を実施した結果、当該事象の再現が確認された事例がありました。 原因は特定でき、修正ソフトウェアの開発を行うことといたしました。 修正ソフトウェアの開発には数ヶ月程度時間を要しますため、まず当該事象の発生の可能性について周知を行う こととし、修正ソフトウェアが開発され次第、修正ソフトウェアへのバージョンアップを行う自主改修を行うこ とといたしました。
危惧される具体的な健康被害
当該事象発生時、当該装置はスタンバイモードに入り、換気開始ボタンを押さない限り換気は再開されません。 しかしながら当該装置使用時には、通常、生体監視モニターが併用され、医療スタッフまたは介護者の監視の 下、 患者さんの状態が常時観察されること、また緊急の場合を想定し、手動式人工呼吸器等、代替手段の準備が行わ れています。 このため、万一、当該事象が発生した場合においても生体監視モニターのアラームが鳴動するため、医療スタッ フまたは介護者が手動式人工呼吸器等の代替手段により患者様に換気を継続させることから、重篤な健康被害発 生の可能性は無いと考えております。 なお、添付文書および取扱説明書の【警告】にて、生体監視モニターとの併用ならびに代替手段の準備について 既に広く周知させて頂いております。 また、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4月10日 (情報提供の開始)
効能・効果又は用途等
本装置は、乳幼児、小児及び成人の人工呼吸に使用される。
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 ： 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 品質保証本部 品質改善部 電話番号： 03-6776-0009