一覧へ戻る


2001年12月5日作成

医療用具回収の概要
(クラスII

 

1. 一般名及び販売名


一般名:成人用人工呼吸器
販売名:人工呼吸器Tバードシリーズ

2. 対象ロット、数量及び出荷時期


製造番号:
  KGHT1554,KGHT1558,KHHT1016,KHHT1019,KHHT1139,KHHT1146,KHHT1301,KHHT1303
  KHHT1304,KHHT1316,KHHT1317,KHHT1322,KHHT1324,KHHT1326,KHHT1367,KHHT1376
  KHHT1401,KHHT1407,KHHT1408,KHHT1418,KHHT1419,KHHT1512,KHHT1513,KHHT1515
  KHHT1601,KHHT1649,KHHT1682,KHHT1865,KHHT1881,KHHT1895,KHHT1896,KHHT1902
  KHHT1970,KHHT1971,KHHT1972,KHHT1973,KHHT1974,KHHT1975,KHHT1976,KHHT1977
  KHHT1978,KHHT1979,KHHT1980,KHHT1981,KHHT2022,KHHT2058,KHHT2063,KHHT2126
  KHHT2133,KHHT2135,KHHT2136,KHHT2143,KHHT2145,KHHT2147,KHHT2148,KHHT2149
  KHHT2151,KHHT2152,KHHT2153,KHHT2155,KHHT2157,KHHT2159,KHHT2164,KHHT2167
  KHHT2170,KHHT2172,KHHT2174,KHHT2188,KHHT2191,KHHT2192,KHHT2203,KHHT2204
  KHHT2264,KHHT2279,KHHT2531,KJHT1000,KJHT1411,KJHT1412,KJHT1420,KJHT1426
  KJHT1428,KJHT1429,KJHT1430,KJHT1431,KJHT1439,KJHT1440,KJHT1445,KJHT1446
  KJHT1447,KJHT1455,KJHT1462,KJHT1475,KJHT1479,KJHT1481,KJHT1483,KJHT1486
  KJHT1487,KJHT1488,KJHT1492,KJHT1542,KJHT1543,KJHT1555,KJHT1559,KJHT1568
  KJHT1569,KJHT1570,KJHT1574,KJHT1581,KJHT1586,KJHT1589,KJHT1592,KJHT1596
  KJHT1599,KJHT1710,KJHT1712,KJHT1713,KJHT1716,KJHT1719,KJHT1720,KJHT1724
  KJHT1804,KJHT1805,KJHT1806,KJHT1814,KJHT1816,KJHT1822,KJHT1824,KJHT1825
  KJHT1827,KJHT1828,KJHT1830,KJHT1832,KJHT2014,KJHT2016,KJHT2031,KJHT2033
  KJHT2036,KJHT2037,KJHT2039,KJHT2049,KJHT2051,KJHT2054,KJHT2061,KJHT2062
  KJHT2081,KJHT2089,KJHT2090,KJHT2095,KJHT2096,KJHT2201,KJHT2205,KJHT2207
  KJHT2212,KJHT2213,KJHT2215,KJHT2219,KJHT2220,KJHT2227,KJHT2229,KJHT2233
  KJHT2234,KJHT2236,KJHT2237,KJHT2239,KJHT2240,KJHT2242,KJHT2243,KJHT2248
  KJHT2250,KJHT2251,KJHT2254,KJHT2254,KJHT2255,KJHT2269,KKHT0686,KKHT0724
  KKHT1335,KKHT1344,KKHT1348,KKHT1350,KKHT1351,KKHT1353,KKHT1362,KKHT1370
  KKHT1371,KKHT1378,KKHT1379,KKHT1381,KKHT1382,KKHT1392,KKHT1406,KKHT1409
  KKHT1416,KKHT1425,KKHT1515,KKHT1600,KKHT1633,KKHT1662,KKHT1667,KKHT1672
  KKHT1674,KKHT1676,KKHT1682,KKHT1685,KKHT1686,KKHT1690,KKHT1696,KKHT1805
  KKHT1807,KKHT1813,KKHT1816,KKHT1817,KKHT1818,KKHT1820,KKHT1821,KKHT1833
  KKHT1855,KKHT1856,KKHT1858,KKHT1861,KKHT1865,KKHT1867,KKHT1868,KKHT1869
  KKHT1871,KKHT1872,KKHT1875,KKHT1876,KKHT1877,KKHT1878,KKHT1880,KKHT1881
  KKHT1882,KKHT1883,KKHT1884,KKHT1886,KKHT1887,KKHT1888,KKHT1890,KKHT1893
  KKHT1894,KKHT1895,KKHT1897,KKHT1899,KKHT2003,KKHT2004,KKHT2005,KKHT2009
  KKHT2010,KKHT2012,KKHT2019,KKHT2021,KKHT2023,KKHT2052,KKHT2053,KKHT2055
  KKHT2056,KKHT2058,KKHT2059,KKHT2060,KKHT2061,KKHT2062,KKHT2063,KKHT2066
  KKHT2068,KKHT2069,KKHT2070,KKHT2071,KKHT2072,KKHT2073,KKHT2074,KKHT2075
  KKHT2076,KKHT2077,KKHT2078,KKHT2079,KKHT2080,KKHT2081,KKHT2082,KKHT2083
  KKHT2086,KKHT2088,KKHT2089,KKHT2091,KKHT2092,KKHT2177,KKHT2178,KKHT2181
  KKHT2185,KKHT2186,KKHT2191,KKHT2199,KKHT2201,KKHT2202,KKHT2203,KKHT2204
  KKHT2205,KKHT2209,KKHT2219,KKHT2220,KKHT2232,KKHT2236,KKHT2239,KKHT2246
  KKHT2247,KKHT2248,KKHT2249,KKHT2251,KKHT2252,KKHT2253,KKHT2254,KKHT2260
  KKHT2270,KKHT2277,KKHT2279,KKHT2283,KKHT2289,KKHT2294,KKHT2301,KKHT2303
  KKHT2305,KKHT2308,KKHT2313,KKHT2314,KKHT2323,KKHT2330,KKHT2500,KKHT2501
  KKHT2502,KKHT2510,KKHT2512,KKHT2515,KKHT2516,KKHT2517,KKHT2519,KKHT2529
  KKHT2530,KKHT2531,KKHT2533,KKHT2535,KKHT2547,KKHT2555,KKHT2557,KKHT2560
  KKHT2564,KKHT2574,KKHT2578,KKHT2581,KKHT2586,KKHT2594,KKHT2599,KKHT2602
  KKHT2603,KKHT2604,KKHT2605,KKHT2608,KKHT2609,KKHT2610,KKHT2611,KKHT2613
  KKHT2615,KKHT2616,KKHT2628,KKHT2631,KKHT2636,KKHT2637,KKHT2640,KKHT2643
  KKHT2644,KKHT2645,KKHT2646,KKHT2647,KKHT2650,KKHT2651,KKHT2652,KKHT2653
  KKHT2654,KKHT2655,KKHT2657,KKHT2659,KKHT2660,KKHT2668,KKHT2670,KKHT2671
  KKHT2673,KKHT2675,KKHT2677,KKHT2678,KKHT2679,KKHT2681,KKHT2682,KKHT2683
  KKHT2688,KKHT2689,KKHT2691,KKHT2694,KKHT2696,KKHT2698,KKHT2699,KKHT2703
  KKHT2715,KKHT2717,KKHT2719,KKHT2721,KKHT2801,KKHT2802,KKHT2803,KKHT2804
  KKHT2809,KKHT2810,KKHT2811,KKHT2812,KKHT2816,KKHT2818,KKHT2822,KKHT2824
  KKHT2825,KKHT2827,KKHT2828,KKHT2829,KKHT2830,KKHT2831,KKHT2832,KKHT2833
  KKHT2834,KKHT2835,KKHT2836,KKHT2837,KKHT2838,KKHT2839,KKHT2840,KKHT2841
  KKHT2842,KKHT2843,KKHT2844,KKHT2845,KKHT2846,KKHT2847,KKHT2848,KKHT2849
  KKHT2850,KKHT2851,KKHT2852,KKHT2853,KKHT2854,KKHT2856,KKHT2857,KKHT2858
  KKHT2859,KKHT2860,KKHT2861,KKHT2862,KKHT2864,KKHT2865,KKHT2866,KKHT2867
  KKHT2868,KKHT2869,KKHT2870,KKHT2871,KKHT2872,KKHT2874,KKHT2875,KKHT2876
  KKHT2879,KKHT2882,KKHT2885,KKHT2886,KKHT2887,KKHT2888,KKHT2891,KKHT2892
  KKHT2893,KKHT2894,KKHT2895,KKHT2896,KKHT2901,KKHT2904,KKHT2905,KKHT2906
  KKHT2907,KKHT2908,KKHT2909,KKHT2910,KKHT2912,KKHT2916,KKHT2972,AAHT1103
  AAHT1104,AAHT1106,AAHT1107,AAHT1116,AAHT1121,AAHT1123,AAHT1125,AAHT1320
  AAHT1323,AAHT1324,AAHT1327,AAHT1328,AAHT1332,AAHT1333,AAHT1334,AAHT1335
  AAHT1337,AAHT1339,AAHT1340,AAHT1342,AAHT1344,AAHT1346,AAHT1347,AAHT1351
  AAHT1354,AAHT1355,AAHT1403,AAHT1404,AAHT1406,AAHT1410,AAHT1411,AAHT1412
  AAHT1415,AAHT1417,AAHT1418,AAHT1419,AAHT1420,AAHT1422,AAHT1425,AAHT1427
  AAHT1428,AAHT1429,AAHT1430,AAHT1431,AAHT1433,AAHT1434,AAHT1438,AAHT1439
  AAHT1441,AAHT1442,AAHT1443,AAHT1445,AAHT1446,AAHT1447,AAHT1449,AAHT1455
  AAHT1462,AAHT1464,AAHT1470,AAHT1471,AAHT1473,AAHT1475,AAHT1481,AAHT1482
  AAHT1485,AAHT1491,AAHT1494,AAHT1495,AAHT1496,AAHT1499,AAHT1512,AAHT1545
  AAHT1554,AAHT1555,AAHT1558,AAHT1560,AAHT1561,AAHT1564,AAHT1566,AAHT1567
  AAHT1569,AAHT1570,AAHT1571,AAHT1572,AAHT1573,AAHT1574,AAHT1575,AAHT1576
  AAHT1577,AAHT1578,AAHT1579,AAHT1581,AAHT1583,AAHT1584,AAHT1585,AAHT1586
  AAHT1587,AAHT1588,AAHT1590,AAHT1596,AAHT1599,AAHT1630,AAHT1645,AAHT1647
  AAHT1648,AAHT1653,AAHT1654,AAHT1700,AAHT1701,AAHT1703,AAHT1707,AAHT1708
  AAHT1711,AAHT1714,AAHT1715,AAHT1716,AAHT1717,AAHT1718,AAHT1719,AAHT1720
  AAHT1721,AAHT1722,AAHT1723,AAHT1724,AAHT1725,AAHT1727,AAHT1728,AAHT1729
  AAHT1730,AAHT1731,AAHT1732,AAHT1733,AAHT1734,AAHT1735,AAHT1736,AAHT1737
  AAHT1738,AAHT1739,AAHT1743,AAHT1744,AAHT1745,AAHT1746,AAHT1747,AAHT1751
  AAHT1755,AAHT1757,AAHT1762,AAHT1763,AAHT1764,AAHT1766,AAHT1767,AAHT1774
  AAHT1775,AAHT1787,AAHT1788,AAHT1797,AAHT1799,AAHT1814,AAHT1816,AAHT1818
  AAHT1821,AAHT1830,AAHT1835,AAHT1837,AAHT1838,AAHT1841,AAHT1842,AAHT1846
  AAHT1847,AAHT1850,AAHT1851,AAHT1854,AAHT1858,AAHT1860,AAHT1863,AAHT1868
  AAHT1870,AAHT1871,AAHT1873,AAHT1874,AAHT1877,AAHT1879,AAHT1881,AAHT1882
  AAHT1890,AAHT1892,AAHT1893,AAHT1896,AAHT1980,AAHT1984,AAHT1988,AAHT1991
  AAHT1997,AAHT2001,AAHT2002,AAHT2003,AAHT2004,AAHT2009,AAHT2020,AAHT2021
  AAHT2026,AAHT2027,AAHT2028,AAHT2030,AAHT2036,AAHT2038,AAHT2039,AAHT2041
  AAHT2044,AAHT2046,AAHT2047,AAHT2048,AAHT2049,AAHT2052,AAHT2053,AAHT2054
  AAHT2055,AAHT2056,AAHT2057,AAHT2058,AAHT2059,AAHT2060,AAHT2061,AAHT2104
  AAHT2106,AAHT2108,AAHT2109,AAHT2111,AAHT2112,AAHT2113,AAHT2116,AAHT2117
  AAHT2118,AAHT2120,AAHT2122,AAHT2126,AAHT2127,AAHT2130,AAHT2135,AAHT2139
  AAHT2146,AAHT2149,AAHT2157,AAHT2162,AAHT2163,AAHT2165,AAHT2167,AAHT2168
  AAHT2169,AAHT2178,AAHT2179,AAHT2181,AAHT2183,AAHT2184,AAHT2186,AAHT2188
  AAHT2189,AAHT2190,AAHT2191,AAHT2192,AAHT2195,AAHT2196,AAHT2197,AAHT2198
  AAHT2199,AAHT2237,AAHT2241,AAHT2258,AAHT2323,AAHT2346,AAHT2375,AAHT2381
  AAHT2386,AAHT2401,AAHT2402,AAHT2405,AAHT2411,AAHT2413,AAHT2414,AAHT2415
  AAHT2417,AAHT2418,AAHT2419,AAHT2420,AAHT2421,AAHT2422,AAHT2423,AAHT2424
  AAHT2425,AAHT2427,AAHT2428,AAHT2430,AAHT2431,AAHT2432,AAHT2434,AAHT2435
  AAHT2436,AAHT2437,AAHT2439,AAHT2441,AAHT2442,AAHT2444,AAHT2445,AAHT2446
  AAHT2447,AAHT2448,AAHT2449,AAHT2450,AAHT2451,AAHT2453,AAHT2456,AAHT2457
  AAHT2459,AAHT2464,AAHT2471,AAHT2476,AAHT2478,AAHT2479,AAHT2487,AAHT2488
  AAHT2491,AAHT2496,AAHT2497,AAHT2501,AAHT2502,AAHT2504,AAHT2506,AAHT2507
  AAHT2513,AAHT2514,AAHT2526,AAHT2527,AAHT2535,AAHT2540,AAHT2543,AAHT2544
  AAHT2546,AAHT2552,AAHT2555,AAHT2556,AAHT2559,AAHT2563,AAHT2564,AAHT2565
  AAHT2567,AAHT2580,AAHT2583,AAHT2584,AAHT2588,AAHT2594,AAHT2595,AAHT2596
  AAHT2622,AAHT2700,AAHT2701,AAHT2704,AAHT2705,AAHT2706,AAHT2708,AAHT2710
  AAHT2712,AAHT2713,AAHT2714,AAHT2715,AAHT2716,AAHT2723,AAHT2725,AAHT2727
  AAHT2730,AAHT2734,AAHT2739,AAHT2740,AAHT2742,AAHT2743,AAHT2744,AAHT2745
  AAHT2746,AAHT2748,AAHT2804,AAHT2807,AAHT2817,ABHT1002,ABHT1031,ABHT1032
  ABHT1033,ABHT1034,ABHT1035,ABHT1036,ABHT1037,ABHT1038,ABHT1040,ABHT1041
  ABHT1042,ABHT1043,ABHT1044,ABHT1047,ABHT1052,ABHT1054,ABHT1055,ABHT1056
  ABHT1100,ABHT1101,ABHT1102,ABHT1103,ABHT1104,ABHT1106,ABHT1107,ABHT1108
  ABHT1113,ABHT1114,ABHT1115,ABHT1116,ABHT1117,ABHT1118,ABHT1119,ABHT1120
  ABHT1121,ABHT1122,ABHT1123,ABHT1124,ABHT1125,ABHT1126,ABHT1127,ABHT1128
  ABHT1130,ABHT1131,ABHT1135,ABHT1136,ABHT1137,ABHT1138,ABHT1139,ABHT1140
  ABHT1141,ABHT1142,ABHT1143,ABHT1146,ABHT1148,ABHT1149,ABHT1150,ABHT1151
  ABHT1153,ABHT1154,ABHT1155,ABHT1156,ABHT1157,ABHT1158,ABHT1159,ABHT1160
  ABHT1161,ABHT1162,ABHT1163,ABHT1164,ABHT1165,ABHT1168,ABHT1170,ABHT1171
  ABHT1172,ABHT1173,ABHT1174,ABHT1175,ABHT1176,ABHT1177,ABHT1178,ABHT1179
  ABHT1180,ABHT1182,ABHT1184,ABHT1185,ABHT1186,ABHT1187,ABHT1189,ABHT1190
  ABHT1191,ABHT1192,ABHT1193,ABHT1195,ABHT1301,ABHT1303,ABHT1306,ABHT1310
  ABHT1317,ABHT1320,ABHT1321,ABHT1324,ABHT1327,ABHT1328,ABHT1332,ABHT1333
  ABHT1334,ABHT1336,ABHT1338,ABHT1339,ABHT1343,ABHT1344,ABHT1348,ABHT1351
  ABHT1352,ABHT1355,ABHT1356,ABHT1357,ABHT1358,ABHT1359,ABHT1360,ABHT1361
  ABHT1363,ABHT1366,ABHT1368,ABHT1377,ABHT1380,ABHT1381,ABHT1383,ABHT1384
  ABHT1385,ABHT1386,ABHT1387,ABHT1388,ABHT1389,ABHT1390,ABHT1391,ABHT1392
  ABHT1393,ABHT1394,ABHT1395,ABHT1396,ABHT1397,ABHT1398,ABHT1399,ABHT1520
  ABHT1522,ABHT1531,ABHT1532,ABHT1534,ABHT1800,ABHT1801,ABHT1803,ABHT1804
  ABHT1805,ABHT1806,ABHT1807,ABHT1808,ABHT1812,ABHT1813,ABHT1814,ABHT1818
  ABHT1825,

出荷数量:1033台
出荷時期:平成9年9月1日から平成13年11月29日まで

3. 製造業者等名称


会社の名称  :アイ・エム・アイ株式会社
本社所在地  :埼玉県越谷市流通団地3−3−12
営業所の名称 :アイ・エム・アイ株式会社
営業所の所在地:埼玉県越谷市流通団地3−3−12
輸入先製造業者:バードプロダクツコーポレーション(米国)

4. 回収理由


 平成13年8月29日、国内の医療施設で当該器械の始業点検中に、アラームが作動し、送気が停止したとの報告がありました。
 故障したタービンを制御する電子基板を輸入先製造業者へ送付し原因究明を行ったところ、基板上のトランジスタと放熱板間の密着が不十分な為に、トランジスタが加熱し、タービンが停止した事が判明しました。
 過去に製造された器械についても、密着不良のものがある可能性がありますので、弊社と致しましては、患者の安全を第一に考え再発を防止する為、該当する全器械について当該電子基板を点検し、不良が確認された場合には改修し、信頼性の向上を図ることに致し
ました。

5. 危惧される具体的な健康被害


 今回のような故障で、送気が停止した場合には、連続音のアラームが必ず作動しますので、手動換気など適切な処置を講ずることにより、患者に重篤な健康被害を及ぼす可能性はありません。
 本不具合による健康被害発生の報告は、国内および国外において受けておりません。

6. 回収開始年月日


平成13年12月 4日

7. 効能・効果又は用途等


 本器械は、ICU、CCUあるいは一般病棟で使用される人工的に呼吸を行わせる器械です。

8. その他


 納入いたしました医療機関および販売会社は全て特定しておりますので、文書にてご通知のうえ改修作業を実施いたします。

9. 担当者名及び連絡先


連絡先  アイ・エム・アイ株式会社 埼玉県越谷市流通団地3−3−12
担当者  技術グループ 品質保障チーム 岡田 利夫
電話番号 048-988-4440
FAX  048-961-1558