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平成31年 4月23日作成 令和3年 9月15日訂正(*)
一般的名称及び販売名
一般的名称： パルスオキシメータ 販売名 ： ベットサイド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
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 MBJ1810110 MBJ1810111 MBJ1810112 MBJ1810113 MBJ1810114 MBJ1810115 MBJ1810116 MBJ1810117 MBJ1810118 MBJ1810119 MBJ1810120 MBJ1810121 MBJ1810122 MBJ1810123 MBJ1810124 MBJ1810125 MBJ1810126 MBJ1810127 MBJ1810128 MBJ1810129 MBJ1810130 MBJ1810131 MBJ1810132 MBJ1810133 MBJ1810134 MBJ1810135 MBJ1810136 MBJ1810137 MBJ1810138 MBJ1810140 MBJ1810141 MBJ1810142 MBJ1810143 MBJ1810144 MBJ1810145 MBJ1810146 MBJ1810147 MBJ1810148 MBJ1810149 MBJ1810150 MBJ1810151 MBJ1810152 MBJ1810153 MBJ1810154 MBJ1810155 MBJ1810156 MBJ1810157 MBJ1810158 MBJ1810159 MBJ1810160 MBJ1810161 MBJ1810162 MBJ1810163 MBJ1810164 MBJ1810165 MBJ1810166 MBJ1810167 MBJ1810168 MBJ1810169 MBJ1810170 MBJ1810171 MBJ1810172 MBJ1810173 MBJ1810174 MBJ1810175 MBJ1810176 MBJ1810177 MBJ1810178 MBJ1810179 MBJ1810180 MBJ1810181 MBJ1810182 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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.(メディアナ・カンパニー・リミッテド）大韓民国
改修理由
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。
危惧される具体的な健康被害
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。
改修開始年月日
平成31年4月23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。
担当者及び連絡先
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