一般名及び販売名

一般名称：その他の人工呼吸器(新生児/小児/成人用人工呼吸器)
販売名　：サーボベンチレータシリーズ
型式名　：サーボi

対象ロット、数量及び出荷時期

製造番号：
1102,1103,1127,1128,1129,1130,1131,1132,1151,1152,1153,1154,1155,1182,1183,
1185,1186,*1187,1192,1194,1195,1196,1202,1203,1204,1205,1206,1207,1208,1209,
1210,1211,1212,1213,1214,1215,1268,1269,1270,1376,1378,1379,1380,1382,1383,
1384,1388,*1389,1390,1391,1393,1394,1395,1397,1402,1403,1406,1408,1409,1410,
1411,1412,1413,1414,1415,1416,1420,1421,1423,1424,1425,1427,1428,1429,1430,
1431,1432,1433,1434,1435,1437,1438,1439,1440,1441,1442,1443,1444,1446,1447,
1448,*1449,1450,1451,1452,1453,1455,1456,1457,1458,1459,1460,1480,1481,1482,
1483,1484,1485,1486,1487,1488,1489,1494,1495,1497,1499,1500,1501,1502,1503,
1533,1534,1535,1537,1538,1539,1540,1541,1542,1548,1549,1550,1551,1552,1553,
1554,1555,1556,1557,1558,1559,1560,1561,1562,1563,1564,1565,1566,1567,1568,
1569,1570,1571,1572,1574,1576,1577,1578,1579,1580,1581,1583,1584,1585,1586,
1587,1588,1589,1590,1591,1592,1593,1594,1595,1596,1597,1628,1629,1630,1631,
1632,1633,1634,1635,1636,1637,*1765,1766,1767,1768,1769,1770,1772,1773,1775,
1776,1777,1778,1779,1780,1781,1783,1784,1785,1786,1787,1788,1789,1790,1802,
1803,1804,1805,1806,1807,*1808,1809,1810,1811,1891,1892,1893,1894,1895,1896,
1897,1898,1899,1900,1903,1904,1905,1906,1907,1908,1909,1910,1911,1912,2033,
2034,2035,2036,2038,2039,2040,2041,2042,2058,2059,2060,2061,2062,2063,2064,
2065,2066,2067,2102,2103,2104,2105,2106,2107,2108,2109,2110,*2111,2141,2142,
2143,2144,2145,2146,2147,2148,2149,*2177,2178,2179,2180,2181,2182,2183,*2184,
2185,2186,2188,2189,2190,2191,2192,2193,2194,2195,2196,2223,2224,2225,*2226,
2229,*2230,*2231,2232,2233,2234,2235,2236,2237,2238,2239,*2241,2242,2243,2244,
2245,2246,2247,2248,2250,*2251,2252,2263,2264,2265,2266,2267,2268,2269,2270,
2271,2272,2275,2276,2277,2278,2279,2280,2281,2282,2283,2284,2291,2293,2294,
2295,2296,2297,2298,2299,2300,2301,2302,2303,2304,2305,2306,2308,2309,2310,
2339,2340,2341,2342,2343,2344,2345,2346,2347,2348,2349,2350,2351,2352,2353,
2354,2355,2356,2357,2358,2359,2360,2361,2362,2363,2364,2365,2366,2367,2368,
2369,2403,2407,2408,2409,2410,2411,2412,2413,2414,2415,2416,2417,2418,2419,
2420,2421,2422,2423,2424,2425,2426,2433,2434,2435,2436,2437,2438,2439,2440,
2441,2442,*2444,2445,2446,2447,2448,2449,2450,2451,2452,2453,2454,*2456,*2457,
2458,2459,2460,2461,2462,*2463,2464,*2465,*2466,2467,2468,*2469,2470,2471,*2472,
2473,2474,2475,2476,2477,2478,2479,2480,2481,2482,2483,2484,2485,2486,2487,
2488,2489,2490,2491,2492,2493,2494,2495,2497,2498,2499,2500,2501,2502,2504,
2505,2506,*2507,2508,2509,2510,2511,2512,2513,2514,2515,2516,2517,2518,2519,
2520,2521,2522,2523,2524,2525,2526,2527,2528,2529,2530,2531,*2532,2533,2534,
2535,2536,2537,2538,2539,2540,2541,2542,2624,2625,2626,2627,2628,*2629,2630,
2631,2632,2633,2634,2635,2636,2637,2638,2639,2640,2641,2642,2643,2644,2645,
2646,2647,2648,2649,2650,2651,2652,2653,3374,3376,3377,3378,*3622,3623,3624,
3625,3626,3627,3628,3629,3630,3631,3632,3633,3634,3635,3637,3638,3639,3640,
3641,3678,*3679,*3680,*3681,*3682,*3683,3684,3685,3686,3687,3747,3748,3749,3750,
3751,3752,3754,3755,3756,3759,3760,3761,*3762,3763,3764,3765,3766,3767,3768,
3769,3770,3771,3772,3773,3774,3775,3776,3777,3778,3863,3864,3865,3866,3867,
3911,3912,3913,3914,3915,3916,3917,3918,3919,3920,3921,3922,3923,3924,3925,
3926,3927,3928,3929,3930,3998,3999,*4000,*4001,4002,*4003,4004,4005,4006,4007,
5349,5350,5351,5352,5353,5354,5355,5356,5357,5358,5520,5521,5522,5523,*5524,
5525,5526,5527,5528,5529,5530,5531,5532,5533,5534,5535,5536,5537,5538,5539,
5540,5541,5542,5543,5544,5701,5702,5703,*5704,5705,5706,5707,5708,5709,5710,
5711,5712,5713,5714,5715,5716,5717,5718,5719,5720,5721,5722,5723,5724,5726,
*5727,5728,5729,5730,5731,5732,5733,5734,5735,5736,5737,5738,5739,5740,5741,
5742,5743,5744,5745,5746,5747,5748,5749,5750,5751,5752,5753,5754,5755,5756,
5757,5758,5759,5760,5761,5762,5764,5765,5766,5767,5769,5771,5773,5774,5775,
5776,5777,5778,5779,5780,5781,5782,5783,5784,5785,5786,5787,5788,5789,5790,
5791,5792,5793,5794,5795,5796,5797,5798,5799,*5800,5889,5890,5891,6016,*6017,
6018,6019,6020,6021,6022,6023,6024,6025,6559,6560,6561,6562,6563,6564,*6565,
6566,6567,6568,6569,*6570,6571,6572,6573,6574,6575,6576,6577,6578,6579,6581,
6582,6583,*6584,*6585,6587,6588,6923,6924,6925,6926,6927,*6928,6929,6930,6931,
6932,7065,7066,7067,7068,7069,7070,7071,7072,7073,7581,7582,7583,7584,7585,
7586,7587,7588,7589,7590,7707,7709,7710,7711,7712,7713,7714,7715,7716,7731,
7732,7733,7734,7735,7736,7737,7738,7739,7740,7743,7744,7745,7746,7747,7748,
7749,7750,7751,7752,7753,7754,7755,7756,7757,7758,7759,7760,7761,7762,7763,
7764,7765,7766,7767,7768,7769,7770,7771,10170,10171,10172,10173,10174,10175,10176,
10177,10178,10179,10286,10287,10288,10289,10290,10291,10292,10293,10294,10295,10346,10347,
10348,10349,10350,10372,10373,10374,10375,10376,10377,10378,10379,10380,10381,10732,10801,
10802,10803,10804,10805,10806,10807,10808,10809,*10810,*10811,10812,10813,10814,10815,*10817,
*10818,*10819,10933,10934,10935,10936,10937,10938,10939,10940,10941,10942,10989,10991,10992,
*10993,10994,10995,10996,10997,11055,11056,11057,11058,11059,11060,11061,11062,11063,11064,
11125,11126,11127,11128,*11129,11130,11131,11132,11133,11135,11136,11137,11138,11139,11140,
11141,11142,11143,11144,11238,11239,11240,11241,11243,11244,11245,11246,11247,11248,11249,
11250,11251,11252,11253,11254,11255,11256,11257,11375,11376,11377,11378,11379,11380,11381,
11382,*11384,11402,11403,11404,11405,11406,11407,11408,11409,11410,11411,11412,11413,11414,
11415,11416,11417,11418,11419,11420,11421,11495,*11496,*11497,11498,11499,11500,11501,11502,
11503,11504,11505,11506,11507,11508,11509,11510,11511,11512,11513,11514,11604,*11605,11606,
11607,11608,*11609,11610,*11611,11612,11613,11637,11638,11639,11640,11641,11642,11643,11644,
11645,11646,11647,11648,11649,11650,11651,11652,11653,11654,11655,11656,11681,*11682,11683,
11684,11685,11686,11687,11688,11689,11690,11691,11692,11693,11694,11695,11696,11697,11698,
11699,11700,*11715,*11716,*11717,*11718,11719,11720,11721,11722,11723,*11724,*11725,11726,11727,
11728,11729,11730,*11731,*11732,*11733,*11734,11735,11736,11737,11739,11740,*11741,11742,11743,
11744,*11747,11748,11749,11750,11751,11752,11754,11755,11756,11757,11758,11759,11760,11761,
11762,11763,11764,11765,11766,11797,11798,*11799,11802,11803,11804,11805,*11806,*11807,11808,
11809,*11810,11812,11813,11814,11815,11816,11909,11910,11911,*11912,11913,11914,11915,*11916,
11917,11918,11919,11920,11921,11922,11923,11924,11925,11926,11927,11928,11983,11984,11985,
11986,11987,11988,11989,11990,11991,11992,11993,11994,11995,11996,11997,*11998,*11999,12000,
12001,12002,12069,12070,12071,*12072,12073,12074,12075,*12076,12077,12078,12079,12080,12081,
12082,12083,12084,12085,12086,12087,12088,12137,12138,12139,12140,12141,12142,12143,12144,
12145,12147,12148,*12149,12150,*12151,*12152,*12153,*12154,12155,12156,*12322,12323,*12324,12325,
12326,12327,*12328,12329,*12330,*12331,*12332,*12333,*12335,*12336,12337,*12338,*12339,*12340,12341,
12355,12356,*12357,*12358,*12359,*12360,12361,12362,12363,12364,12365,12366,*12367,12368,12369,
12370,12371,12372,12373,*12374,12375,*12376,12377,*12378,*12379,*12380,*12381,*12382,*12383,*12384,
12567,12568,12569,12570,12571,12572,*12573,*12574,12575,*12579,*12580,*12582,*12583,*12584,12585,
13106,13107,13108,13109,13110,13111,13112,13113,13114,13115,13181,13182,13183,13184,13185,
13186,13187,13188,13189,13190,13205,13206,13207,13208,13209,13210,13211,13212,13214,
出荷数量　：*１３４９台
出荷時期：平成１３年８月〜平成１６年９月

製造業者等名称

営業所の名称　：フクダ電子株式会社
営業所の所在地：東京都文京区本郷二丁目35番27号　たかぎビル
薬事の業態　　：医療用具輸入販売業
業許可番号　　：１３ＢＹ０９０２
輸入先製造元　：マッケ　クリティカルケア　AB社（スウェーデン）

改修理由

交流電源にて駆動中に機器の電源に異常が発生しバッテリー駆動になったとの報告が
医療機関よりありました。調査したところ電源基板にあるチップ部品のコンデンサーに
物理的な力が加わると微細なひび(マイクロクラック)が入り、稀に発熱、焼損し機器が
停止する可能性のある事が判明しました。上記不良発生の可能性が否定出来ないため、
患者様の安全を第一に考え、改修致します。

危惧される具体的な健康被害

本件の不具合が患者様への使用中に発生し交流電源による駆動が停止した場合、
バッテリー駆動に切り替わります。切り替わる時にアラームが作動し当該事象の発生を
知ることが出来ます。またバッテリー駆動時間の残り10分、3分で再度、アラームが作動
しバッテリー駆動中であることを知ることが出来ますので、適切な対処をとる事により
重篤な健康被害を回避出来ます。
なお、現在までに本不具合による健康被害の報告は受けておりません。

改修開始年月日

平成１６年９月２２日（情報提供開始日）

効能・効果又は用途等

人工的に呼吸を行なわせる装置です。

その他

本件に係わる装置の納入先は全て把握しており、納入先へ情報を提供するとともに改修を実施致します。

担当者名及び連絡先

連　絡　先：フクダ電子株式会社　広報・ＩＲ部
住　　　所：東京都文京区本郷三丁目３９番４号
　　　　　　電話　０３（５６８４）１５５８（直通）
　　　　　　FAX　 ０３（５６８４）１５７７
担当者氏名：安倍　誠