平成25年 6月20日作成

一般的名称： 成人用人工呼吸器
販売名　　： Ｖ６０ベンチレータ

製造番号：

100019386,100019387,100019388,100019391,100019393,100019395,100019396,100019399,100019611,
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100080728,100080729,100080730,100080731,100080732,100080733,100080734,100080735,100080736,
100080737,100080738,100080739,100080740,100080840,100080841,100080843,100080844,100080845,
100080846,100080847,100080848,100080849,100080850,100080851,100080852,100081698,100081716,
201001557,201001558,201001559,201001560,201001561,201001562,201001563,201001564,201001565,
201001566,201001567,201001569,201001572,201001574,201001575,201001577,201001578,201001579,
201001855,201001856,201001857,201001858,201001859,201001860,201001861,201001862,201001864,
201001866,201001867,201001868,201001869,201001948,201001951,201001990,201001991,201001992,
201001993,201001994,201001995,201001996,201001997,201001998,201001999,201002040,201002042,
201002043,201002045,201002046,201002047,201002048,201002140,201002171,201002172,201002173,
201002175,201002176,201002177,201002178,201002179,201002221,201002222,201002223,201002224,
201002225,201002226,201002227,201002228,201002230,201002293,201002294,201002298,201002299,
201002300,201002303,201002305,201002306,201002331,201002332,201002333,201002334,201002335,
201002336,201002337,201002339,201002341,201002342,201002343,201002344,201002345,201002346,
201002347,201002348,201002349,201002350,201002351,201002352,201002353,201002354,201002355,
201002356,201002542,201002543,201002743,201002919,201003041,201003049,201003053,201003055,
201003057,201003063,201003065,201003073,201003075,201003077,201003078,201003079,201003080,
201003081,201003083,201003085,201003086,201003087,201003089,201003091,201003092,201003094,
201003096,201003098,201003099,201003100,201003101,201003103,201003107,201003110,201003111,
201003112,201003113,201003114,201003115,201003116,201003117,201003118,201003119,201003120,
201003121,201003122,201003123,201003124,201003360,201003381,201003389,201003391,201003408,
201003414,201003427,201003429,201003432,201003433,201003434,201003438,201003440,201003441,
201003442,201003444,201003446,201003448,201003450,201003451,201003452,201003453,201003454,
201003455,201003456,201003457,201003458,201003459,201003462,201003464,201003465,201003467,
201003470,201003471,201003472,201003474,201003476,201003477,201003480,201003484,201003486,
201003487,201003489,201003491,201003495,201003496,201003497,201003498,201003499,201003501,
201003944,201003945,201003946,201003947,201003949,201003950,201003951,201003953,201003954,
201003955,201003956,201003957,201003958,201004248,201004250,201004251,201004254,201004256,
201004342,201004343,201004344,201004345,201004346,201004347,201004348,201004350,201004352,
201004356,201004359,201004360,201004361,201004365,201004373,201004384,201004393,201004437,
201004438,201004439,201004460,201004461,201004586,201004587,201004588,201004589,201004590,
201004591,201004592,201004628,201004630,201004635,201004637,201004641,201004643,201004693,
201004694,201004695,201004696,201004697,

対象数量：　2,182台

出荷時期：　2010年11月21日〜2013年6月8日

製造販売業者の名称　： フィリップス・レスピロニクス合同会社
製造販売業者の所在地： 埼玉県さいたま市北区宮原町 1-825-1
許可の種類　　　　　： 第一種医療機器製造販売業
許可番号　　　　　　： 11B1X00022
輸入先製造業者名　　：レスピロニクス　カリフォルニア社
　　　　　　　　　　　　（Respironics California,Inc.） アメリカ合衆国

海外製造元であるレスピロニクス　カリフォルニア社の製品モニタリングの過程で、パワーマネージメント基
板（ＰＭ基板）を操作するファームウエアに不具合があることが検出されました。この不具合があることで、
ＰＭ基板の半導体素子に故障が発生しシャットダウンした場合に、ＰＭ基板のファームウエアが異常なシャッ
トダウンと判断せず、セルフテスト（POST）を繰り返しアラームが鳴らない可能性があります。
この半導体素子の故障が発生する確率は0.05％と低い値ではありますが、患者様の安全・品質向上を考慮し、
ＰＭ基板のファームウエアソフトを変更する措置を海外および日本国内で実施いたします。

当該製品は「警報機能付きパルスオキシメータ」又は「警報装置付きカプノメータ」等の別の生体モニター装置
を併用して資格を持つ医療従事者による適切な監視の下で使用する医療機器であり、このことは、添付文書の警
告欄に記載してあります。これにより、当該医療機器に上記４の事象が発生した場合でも、他の装置より異常を
示す警報が発せられるため、直ちに必要な措置が採られ重篤な健康被害が発生することはないと考えます。
現在までに海外では軽度の呼吸困難は報告されているものの、重篤な健康被害は報告されていません。また国内
では健康被害の報告はありません。

平成25年6月18日　(情報提供の開始）

本装置は器械的人工呼吸による補助が必要な患者を対象とした成人用および小児用の人工呼吸器であり、呼吸不
全、慢性呼吸不全、閉塞性睡眠時無呼吸の患者の呼吸を補助するために使用する。

出荷先はすべて把握しておりますので、文書で連絡の上、回収を実施します。

担当者　： 草間　薫
連絡先　： フィリップス・レスピロニクス合同会社
　　　　　 宮原事業所 品質保証センター 市販後管理
電話番号： 0120-633-881
FAX番号 ： 048-662-6592