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令和元年 6月17日作成
一般的名称及び販売名
一般的名称: 汎用血液ガス分析装置 販売名 : 血液分析器GASTAT‐navi
対象ロット、数量及び出荷時期
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11230707, 11231707, 11232707, 11233707, 11234707, 11235707, 11236707, 11237707, 11238707, 11239707, 11240707, 11241707, 11242707, 11243707, 11244707, 11245707, 11246707, 11247707, 11251707, 11252707, 11253707, 11254707, 11255707, 11256707, 11257707, 11258707, 11259707, 11261707, 11262707, 11263707, 11264707, 11265707, 11266707, 11267707, 11268707, 11269707, 11270707, 11271707, 11272707, 11273707, 11274707, 11275707, 11276707, 11277707, 11278707, 11279707, 11280707, 11281707, 11282707, 11283707, 11284707, 11285707, 11286707, 11287707, 11288707, 11289707, 11290707, 11292707, 11293707, 11294707, 11295707, 11296707, 11297707, 11298707, 11299707, 11300707, 11301707, 11302707, 11303707, 11304707, 11305707, 11306707, 11307707, 11308707, 11309707, 11310707, 11314707, 11315707, 11316707, 11317707, 11318707, 11319707, 11320707, 11331707, 11332707, 11333707, 11334707, 11335707, 11336707, 11337707, 11338707, 11339707, 11340707, 11343707, 11345707, 11346707, 11347707, 11348707, 11349707, 11350707, 11351707, 11352707, 11353707, 11354707, 11355707, 11356707, 11357707, 11358707, 11359707, 11365707, 11366707, 11367707, 11368707, 11369707, 11370707, 11371707, 11374707, 11375707, 11376707, 11377707, 11378707, 11379707, 11380707, 11381707, 11382707, 11386707, 11387707, 11388707, 11389707, 11391707, 11393707, 11394707, 11395707, 11396707, 11397707, 11398707, 11399707, 11400707, 11402707, 11403707, 11410707, 11415707, 11416707, 11417707, 11418707, 11419797, 11420707, 11421707, 11422707, 11423707, 11424707, 11425707, 11426707, 11427707, 11428707, 11429707, 11432707, 11433707, 11434707, 11435707, 11436707, 11437707, 11438707, 11439707, 11440707, 11443707, 11444707, 11445707, 11446707, 11447707, 11449707, 11450707, 11451707, 11452707, 11453707, 11454707, 11455707, 11456707, 11457707, 11458707, 11459707, 11460707, 11466707, 11467707, 11468707, 11469707, 11470707, 11471707, 11472707, 11473707, 11474707, 11475707, 11476707, 11477707, 11478707, 11496707, 11497707, 11498707, 11499707, 11500707, 12002808, 12003808, 12004808, 12005808, 12006808, 12008808, 12009808, 12010808, 12011808, 12103808, 出荷数量:1906台 出荷時期:平成22年1月〜令和元年5月
製造販売業者等名称
製造販売業者の名称 : 株式会社テクノメディカ 製造販売業者の所在地: 神奈川県横浜市都筑区仲町台5丁目5番1号 許可の種類 : 第二種医療機器製造販売業 許可番号 : 14B2X00034
回収理由
本製品に附属品のセンサーカードを挿入後、予備加温の状態で、しばらく待っても測定に移行しないため センサーカードを取り出したところ、センサーカードの一部が発熱しており、操作者が触れて軽度の火傷を負う 事例が1件報告されました。調査したところ、本製品のセンサーカード検知部信号が一瞬オフとなり、直ぐ(3秒 以内)にオンとなった場合に、測定動作は中断するものの予備加温を継続する事象が確認されました。センサー カードの当該発熱部は、センサカードのセンサー部保護のために、触れないよう注意喚起されていることもあ り、本事象が発生する可能性は低いものと考えておりますが、再発予防のため本製品のソフトウェアの自主回収 を行うことと致しました。
危惧される具体的な健康被害
当該事象は、予備加温中に発生し測定動作へは移行しません。測定結果が出ないため、当該製品の使用による患 者の重篤な健康被害発生の恐れはありません。
回収開始年月日
令和元年6月17日
効能・効果又は用途等
本品は、専用センサーカードを用いて、動脈血中のpH / pCO2 / pO2 / Hct / cNa+ / cK+ / cCa2+を測定する装 置です。
その他
出荷先等の情報は下記の通り。 出荷数 1906台 出荷先施設数 1752施設
担当者及び連絡先
担当者 : 徳川 竜治 連絡先 : 神奈川県横浜市都筑区仲町台5丁目5番1号 電話番号: 045-948‐1961 FAX番号 : 045-948‐1962