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令和 2年 2月25日作成
一般的名称及び販売名
一般的名称： 汎用人工呼吸器 販売名 ： (1)クリーンエア VELIA (2)NIPネーザルV
対象ロット、数量及び出荷時期
製品名 ：クリーンエア VELIA 製造番号： 81040755B 81040756B 81040757B 81040758B 81040759B 81040760B 81040761B 81040762B 81040763B 81040764B 81040765B 81040766B 81040767B 81040768B 81040769B 81040770B 81040771B 81040772B 81040773B 81040774B 81040775B 81040776B 81050777B 81050778B 81050779B 81050780B 81050781B 81050782B 81050783B 81050784B 81050785B 81050786B 81050787B 81050788B 81050789B 81050790B 81050791B 81050792B 81050793B 81050794B 81050795B 81050796B 81050797B 81050798B 81050799B 81050800B 81050801B 81050802B 81050803B 81050804B 81050805B 81050806B 81060807B 81060808B 81060809B 81060810B 81060811B 81060812B 81060813B 81060814B 81060815B 81060816B 81060817B 81060818B 81060819B 81060820B 81060821B 81060822B 81060823B 81060824B 81060825B 81060826B 81060827B 81060828B 81060829B 81060830B 81060831B 81060832B 81060833B 81060834B 81060835B 81060836B 81060837B 81060838B 81060839B 81060840B 81060841B 81060842B 81060843B 81060844B 81070845B 81070846B 81070847B 81070848B 81070849B 81070850B 81070851B 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製造販売業者等名称
製造販売業者の名称 ： レスメド株式会社 製造販売業者の所在地： 東京都千代田区岩本町三丁目２番４号 岩本町ビル 許可の種類 ： 第一種医療機器製造販売業 許可番号 ： 13B1X10062 製造業者名称：ResMed Pty Ltd（オーストラリア）
改修理由
製造元からの報告により、ソフトウェアおよび部品の不良が重なった場合に、作動したアラームは装置の 画面上に表示されるものの、アラームブザーが正常に機能しない可能性が判明しました。 現在製造元において、この問題への修正対応策を準備しており、準備が整うまでの間、まず当該事象の 発生の可能性と取扱説明書の基本説明および使用前点検の再確認を周知し、修正対応の準備が出来次第、 自主回収（改修）を行う事としました。
危惧される具体的な健康被害
ソフトウェアおよび部品の不良が重なった場合に、作動したアラームは装置の画面上に表示されるものの、 アラームブザーが正常に機能しない可能性がありますが、使用目的通り使用し、取扱説明書等に記載されて いる通り機能テスト、アラーム作動確認等を実施する事で本事象の発生を防ぐ事が可能なことから重篤な健 康被害に至る可能性はありません。
改修開始年月日
令和2年2月25日 （情報提供の開始）
効能・効果又は用途等
本装置は、自発呼吸を有する、成人および小児（13 kg以上）の呼吸不全に対する呼吸補助を目的として います。本装置は非侵襲的または侵襲的（リークポートと併用時）に使用することができます。本装置は、 医療機関や在宅における使用、または車椅子などの移動に使用できます。人工換気の短期中断に耐えられな い患者に対する本装置の使用は禁忌・禁止です。
その他
出荷先は全て把握しておりますので、まずはお客様文書を配布し取扱説明書の基本説明および使用前点検の再確 認を周知し、修正対応の準備が出来た時点で、回収（改修）を実施します。
担当者及び連絡先
担当者 ： 帯金 恵 森下 雅夫 連絡先 ： レスメド株式会社 技術統括部 電話番号： 03-5829-4410 FAX番号 ： 03-3863-2250