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平成30年 2月16日作成
一般的名称及び販売名
一般的名称： 半自動除細動器 販売名 ： (1)シーユーＳＰ１ (2)ジェイパッドＣＵ‐ＳＰ１
対象ロット、数量及び出荷時期
（１）シーユーＳＰ１ 数量 ８７６台 出荷時期 ２０１４年９月 〜 ２０１５年１月 G1M36U0108 G1M44B0463 G1M36U0111 G1M36U0116 G1M36U0120 G1M36U0124 G1M36U0127 G1M36U0129 G1M36U0131 G1M36U0136 G1M36U0139 G1M36U0140 G1M36U0145 G1M36U0160 G1M36U0161 G1M36U0163 G1M36U0164 G1M36U0165 G1M36U0166 G1M36U0167 G1M36U0168 G1M36U0169 G1M36U0170 G1M36U0110 G1M36U0172 G1M36U0173 G1M36U0174 G1M36U0175 G1M36U0176 G1M36U0177 G1M36U0178 G1M44B0374 G1M36U0181 G1M36U0182 G1M36U0186 G1M36U0188 G1M36U0191 G1M36U0192 G1M36U0193 G1M36U0194 G1M36U0196 G1M36U0197 G1M36U0198 G1M36U0199 G1M36U0200 G1M36U0201 G1M36U0202 G1M36U0203 G1M36U0204 G1M36U0205 G1M36U0207 G1M36U0208 G1M36U0209 G1M36U0212 G1M36U0213 G1M36U0214 G1M36U0215 G1M36U0216 G1M36U0218 G1M36U0222 G1M36U0223 G1M36U0224 G1M36U0225 G1M36U0228 G1M36U0230 G1M36U0232 G1M36U0233 G1M36U0234 G1M36U0235 G1M36U0236 G1M36U0237 G1M36U0238 G1M36U0239 G1M36U0240 G1M36U0242 G1M36U0244 G1M36U0245 G1M36U0246 G1M36U0247 G1M36U0249 G1M36U0250 G1M36U0251 G1M36U0252 G1M36U0253 G1M36U0254 G1M36U0255 G1M36U0256 G1M36U0259 G1M36U0260 G1M36U0261 G1M36U0262 G1M36U0263 G1M36U0264 G1M36U0266 G1M36U0267 G1M36U0268 G1M36U0269 G1M36U0270 G1M36U0271 G1M36U0272 G1M36U0275 G1M36U0276 G1M36U0277 G1M36U0419 G1M36U0420 G1M36U0423 G1M36U0429 G1M36U0438 G1M36U0443 G1M36U0445 G1M36U0446 G1M36U0448 G1M36U0450 G1M36U0452 G1M36U0453 G1M36U0454 G1M36U0455 G1M36U0456 G1M36U0457 G1M36U0474 G1M36U0475 G1M36U0489 G1M36U0499 G1M36U0500 G1M39V0001 G1M39V0002 G1M39V0003 G1M39V0004 G1M39V0005 G1M39V0007 G1M39V0010 G1M39V0011 G1M39V0012 G1M39V0013 G1M39V0014 G1M39V0015 G1M44B0440 G1M39V0017 G1M39V0018 G1M44B0444 G1M44A0280 G1M44B0335 G1M39V0024 G1M39V0025 G1M39V0028 G1M39V0029 G1M39V0030 G1M39V0033 G1M39V0034 G1M39V0035 G1M39V0036 G1M39V0037 G1M39V0038 G1M39V0040 G1M39V0041 G1M44B0118 G1M39V0044 G1M39V0046 G1M39V0047 G1M39V0051 G1M39V0052 G1M39V0054 G1M39V0056 G1M39V0057 G1M39V0058 G1M39V0059 G1M39V0061 G1M39V0062 G1M39V0064 G1M39V0065 G1M39V0066 G1M39V0067 G1M39V0068 G1M39V0069 G1M39V0073 G1M39V0076 G1M39V0077 G1M39V0079 G1M44B0312 G1M39V0081 G1M39V0083 G1M44B0448 G1M39V0085 G1M39V0087 G1M39V0088 G1M39V0091 G1M39V0092 G1M39V0094 G1M39V0095 G1M39V0096 G1M39V0097 G1M39V0098 G1M39V0100 G1M39V0022 G1M39V0102 G1M39V0103 G1M39V0104 G1M39V0105 G1M39V0107 G1M39V0108 G1M39V0109 G1M39V0111 G1M39V0112 G1M39V0115 G1M39V0116 G1M39V0118 G1M36U0180 G1M39V0123 G1M39V0125 G1M39V0126 G1M39V0127 G1M39V0128 G1M39V0129 G1M39V0131 G1M39V0133 G1M39V0134 G1M39V0135 G1M39V0137 G1M39V0139 G1M39V0140 G1M39V0141 G1M39V0142 G1M39V0143 G1M39V0144 G1M39V0145 G1M44B0467 G1M39V0150 G1M39V0153 G1M39V0154 G1M39V0156 G1M39V0158 G1M39V0159 G1M39V0160 G1M39V0161 G1M39V0162 G1M39V0163 G1M39V0164 G1M39V0167 G1M39V0168 G1M39V0170 G1M39V0171 G1M39V0172 G1M39V0174 G1M39V0175 G1M39V0176 G1M39V0177 G1M39V0178 G1M39V0179 G1M39V0180 G1M39V0181 G1M39V0182 G1M39V0183 G1M39V0184 G1M39V0187 G1M39V0189 G1M39V0190 G1M39V0191 G1M39V0192 G1M39V0193 G1M39V0194 G1M39V0195 G1M39V0196 G1M39V0197 G1M39V0198 G1M39V0199 G1M39V0200 G1M39V0201 G1M39V0202 G1M39V0204 G1M39V0205 G1M39V0206 G1M39V0207 G1M39V0210 G1M39V0211 G1M39V0212 G1M39V0214 G1M39V0216 G1M39V0217 G1M39V0218 G1M39V0219 G1M39V0220 G1M39V0221 G1M39V0223 G1M39V0227 G1M39V0228 G1M39V0230 G1M39V0231 G1M39V0232 G1M39V0233 G1M39V0235 G1M39V0236 G1M39V0237 G1M39V0239 G1M39V0240 G1M39V0241 G1M39V0244 G1M39V0245 G1M39V0246 G1M39V0248 G1M39V0249 G1M39V0251 G1M39V0252 G1M39V0253 G1M39V0254 G1M39V0255 G1M39V0256 G1M39V0257 G1M39V0258 G1M39V0259 G1M39V0260 G1M39V0262 G1M39V0263 G1M39V0265 G1M39V0270 G1M39V0271 G1M39V0274 G1M39V0275 G1M39V0276 G1M39V0278 G1M39V0279 G1M39V0282 G1M39V0283 G1M39V0284 G1M39V0286 G1M39V0287 G1M39V0288 G1M39V0289 G1M39V0290 G1M39V0291 G1M39V0292 G1M39V0293 G1M39V0294 G1M39V0295 G1M39V0296 G1M39V0297 G1M39V0298 G1M39V0299 G1M39V0301 G1M39V0302 G1M39V0303 G1M39V0304 G1M39V0306 G1M39V0307 G1M39V0310 G1M39V0312 G1M39V0313 G1M39V0314 G1M39V0493 G1M39V0318 G1M40X0207 G1M39V0321 G1M44B0302 G1M39V0324 G1M39V0325 G1M39V0327 G1M39V0331 G1M39V0332 G1M39V0334 G1M39V0335 G1M39V0336 G1M39V0338 G1M39V0339 G1M39V0340 G1M39V0343 G1M39V0344 G1M39V0345 G1M39V0347 G1M39V0348 G1M39V0350 G1M39V0354 G1M39V0359 G1M44B0026 G1M39V0362 G1M39V0363 G1M39V0365 G1M39V0366 G1M39V0367 G1M39V0368 G1M39V0370 G1M39V0371 G1M39V0375 G1M39V0377 G1M39V0383 G1M39V0384 G1M39V0385 G1M39V0386 G1M39V0387 G1M39V0388 G1M39V0389 G1M39V0390 G1M39V0391 G1M39V0392 G1M39V0393 G1M39V0394 G1M39V0395 G1M39V0401 G1M39V0402 G1M39V0403 G1M39V0328 G1M39V0405 G1M39V0406 G1M39V0407 G1M44A0202 G1M39V0410 G1M39V0411 G1M39V0412 G1M39V0414 G1M39V0415 G1M39V0416 G1M39V0417 G1M39V0418 G1M39V0423 G1M39V0425 G1M39V0426 G1M39V0429 G1M39V0430 G1M39V0451 G1M39V0433 G1M39V0434 G1M39V0435 G1M39V0438 G1M39V0490 G1M39V0440 G1M39V0441 G1M39V0442 G1M39V0444 G1M39V0446 G1M39V0448 G1M39V0449 G1M39V0450 G1M39V0408 G1M39V0452 G1M39V0454 G1M39V0456 G1M39V0315 G1M39V0459 G1M39V0461 G1M39V0462 G1M39V0463 G1M39V0464 G1M39V0470 G1M39V0471 G1M39V0351 G1M39V0473 G1M39V0474 G1M39V0475 G1M39V0476 G1M39V0477 G1M39V0478 G1M39V0480 G1M39V0481 G1M39V0482 G1M39V0483 G1M39V0082 G1M39V0486 G1M39V0487 G1M39V0404 G1M39V0016 G1M39V0495 G1M39V0497 G1M40X0110 G1M40X0112 G1M40X0115 G1M40X0116 G1M40X0117 G1M40X0118 G1M40X0119 G1M40X0120 G1M40X0122 G1M40X0123 G1M40X0124 G1M40X0126 G1M40X0127 G1M40X0128 G1M40X0129 G1M40X0131 G1M40X0132 G1M40X0133 G1M40X0134 G1M40X0135 G1M40X0136 G1M40X0137 G1M40X0140 G1M40X0143 G1M40X0144 G1M40X0145 G1M40X0146 G1M40X0150 G1M40X0151 G1M40X0154 G1M40X0155 G1M40X0156 G1M40X0157 G1M40X0158 G1M40X0159 G1M40X0162 G1M40X0163 G1M40X0164 G1M40X0165 G1M40X0167 G1M40X0168 G1M40X0175 G1M40X0178 G1M40X0179 G1M40X0184 G1M40X0186 G1M40X0187 G1M40X0189 G1M40X0190 G1M40X0191 G1M40X0193 G1M40X0195 G1M40X0196 G1M40X0197 G1M40X0198 G1M40X0199 G1M40X0200 G1M40X0201 G1M40X0202 G1M40X0203 G1M40X0204 G1M40X0206 G1M40X0208 G1M40X0209 G1M40X0210 G1M40X0211 G1M40X0264 G1M40X0272 G1M40X0273 G1M44A0001 G1M44A0003 G1M44A0004 G1M44A0006 G1M44A0007 G1M44A0010 G1M44A0011 G1M44A0012 G1M44A0013 G1M44A0015 G1M44A0016 G1M44A0019 G1M44A0020 G1M44A0022 G1M44A0026 G1M44A0028 G1M44A0031 G1M44A0032 G1M44A0036 G1M44A0042 G1M44A0044 G1M44A0045 G1M44A0050 G1M44A0054 G1M44A0055 G1M44A0056 G1M44A0058 G1M44A0062 G1M44A0068 G1M44A0071 G1M44A0072 G1M44A0078 G1M44A0084 G1M44A0087 G1M44A0088 G1M44A0089 G1M44A0090 G1M44A0091 G1M44A0094 G1M44A0096 G1M44A0110 G1M44A0111 G1M44A0113 G1M44A0114 G1M44A0115 G1M44A0117 G1M44A0121 G1M44A0122 G1M44A0125 G1M44A0128 G1M44A0132 G1M44A0138 G1M44A0151 G1M44A0153 G1M44A0157 G1M44A0159 G1M44A0165 G1M44A0169 G1M44A0172 G1M44A0173 G1M44A0174 G1M44A0175 G1M44A0176 G1M44A0178 G1M44A0180 G1M44A0182 G1M44A0183 G1M44A0186 G1M44A0193 G1M44A0197 G1M44A0198 G1M44A0200 G1M44A0203 G1M44A0204 G1M44A0205 G1M44A0206 G1M44A0207 G1M44A0208 G1M44A0209 G1M44A0211 G1M44A0212 G1M44A0213 G1M44A0214 G1M44A0215 G1M44A0217 G1M44A0218 G1M44A0219 G1M44A0227 G1M44A0228 G1M44A0229 G1M44A0230 G1M44A0231 G1M44A0241 G1M44A0244 G1M44A0246 G1M44A0247 G1M44A0248 G1M44A0249 G1M44A0251 G1M44A0252 G1M44A0253 G1M44A0254 G1M44A0257 G1M44A0258 G1M44A0259 G1M44A0260 G1M44A0262 G1M44A0263 G1M44A0265 G1M44A0266 G1M44A0267 G1M44A0270 G1M44A0271 G1M44A0273 G1M44A0274 G1M44A0276 G1M44A0277 G1M44A0279 G1M44A0281 G1M44A0283 G1M44A0285 G1M44A0286 G1M44A0289 G1M44A0291 G1M44A0292 G1M44A0308 G1M44A0309 G1M44A0310 G1M44A0311 G1M44A0313 G1M44A0316 G1M44A0319 G1M44A0320 G1M44A0321 G1M44A0324 G1M44A0328 G1M44A0329 G1M44A0330 G1M44A0346 G1M44A0347 G1M44A0348 G1M44A0349 G1M44A0351 G1M44A0352 G1M44A0353 G1M44A0354 G1M44A0355 G1M44A0357 G1M44A0358 G1M44A0359 G1M44A0360 G1M44A0361 G1M44A0362 G1M44A0363 G1M44A0364 G1M44A0365 G1M44A0366 G1M44A0368 G1M44A0370 G1M44A0374 G1M44A0376 G1M44A0377 G1M44A0378 G1M44A0380 G1M44A0381 G1M44A0382 G1M44A0384 G1M44A0385 G1M44A0387 G1M44A0393 G1M44A0478 G1M44B0002 G1M44B0003 G1M44B0004 G1M44B0005 G1M44B0007 G1M44B0008 G1M44B0010 G1M44B0011 G1M44B0012 G1M44B0014 G1M44B0015 G1M44B0016 G1M44B0017 G1M44B0018 G1M44B0019 G1M44B0020 G1M44B0021 G1M44B0022 G1M44B0023 G1M44B0024 G1M44B0025 G1M44B0027 G1M44B0028 G1M39V0138 G1M44B0030 G1M44B0031 G1M44B0032 G1M44B0033 G1M44B0035 G1M44B0037 G1M44B0038 G1M44B0041 G1M44B0042 G1M44B0067 G1M44B0068 G1M44B0069 G1M44B0071 G1M44A0356 G1M44B0073 G1M44B0074 G1M44B0075 G1M44B0076 G1M44B0077 G1M44B0080 G1M44B0081 G1M44B0082 G1M44B0084 G1M44B0085 G1M44B0086 G1M44B0087 G1M44B0088 G1M44B0090 G1M44B0091 G1M44B0092 G1M36U0171 G1M44B0094 G1M44B0097 G1M44B0099 G1M44B0100 G1M44B0105 G1M44B0106 G1M44B0117 G1M44A0350 G1M44B0119 G1M44B0122 G1M44B0079 G1M44B0124 G1M44B0125 G1M44B0126 G1M44B0127 G1M44B0129 G1M44B0131 G1M44B0132 G1M44B0222 G1M44B0224 G1M44B0226 G1M44B0227 G1M44B0272 G1M44B0273 G1M44B0274 G1M44B0275 G1M44B0276 G1M44B0277 G1M44B0278 G1M44B0279 G1M44B0036 G1M44B0281 G1M44B0282 G1M44B0283 G1M44B0284 G1M44B0285 G1M44B0029 G1M44B0287 G1M44B0288 G1M44B0292 G1M44B0294 G1M44B0300 G1M44B0462 G1M44B0304 G1M44B0306 G1M44B0307 G1M44B0310 G1M44B0311 G1M44B0093 G1M44B0313 G1M44B0314 G1M44B0315 G1M44B0317 G1M44B0318 G1M44B0319 G1M44B0321 G1M44B0322 G1M44B0323 G1M44B0324 G1M44B0325 G1M44B0326 G1M44B0329 G1M44B0331 G1M44B0332 G1M44B0333 G1M44B0334 G1M44B0453 G1M44B0336 G1M44B0337 G1M44B0342 G1M44B0345 G1M44B0347 G1M44B0348 G1M39V0364 G1M44B0350 G1M44B0351 G1M44B0360 G1M44B0362 G1M44B0363 G1M44B0364 G1M44B0365 G1M44B0367 G1M44B0368 G1M44B0369 G1M44B0370 G1M39V0042 G1M44B0301 G1M44B0377 G1M44B0395 G1M44B0439 G1M44B0447 G1M39V0101 G1M39V0319 G1M39V0374 G1M44B0454 G1M44B0459 G1M44B0461 G1M44B0465 G1M44B0466 G1M44B0468 G1M44B0469 G1M44B0470 G1M44B0472 G1M44B0473 G1M44B0474 G1M44B0475 G1M44B0477 G1M44B0478 G1M44B0481 G1M44B0490 G1M44B0489 G1M44B0492 G1M44B0493 G1M44B0495 G1M44B0494 G1M44B0498 G1M44B0496 G1M44B0412 G1M44B0196 G1M44B0499 G1M44B0471 （２）ジェイパッドＣＵ‐ＳＰ１ 数量 ４５９ 台 出荷時期 ２０１４年９月 〜 ２０１５年１月 G1M36U0009 G1M36U0011 G1M36U0012 G1M36U0013 G1M36U0014 G1M36U0015 G1M36U0016 G1M36U0017 G1M36U0018 G1M36U0019 G1M36U0020 G1M36U0021 G1M36U0022 G1M36U0023 G1M36U0024 G1M36U0025 G1M36U0026 G1M36U0027 G1M36U0028 G1M36U0029 G1M36U0030 G1M36U0031 G1M36U0032 G1M36U0033 G1M36U0034 G1M36U0035 G1M36U0036 G1M36U0037 G1M36U0038 G1M36U0039 G1M36U0040 G1M36U0041 G1M36U0043 G1M36U0044 G1M36U0045 G1M36U0046 G1M36U0048 G1M36U0049 G1M36U0050 G1M36U0051 G1M36U0052 G1M36U0053 G1M36U0054 G1M36U0055 G1M36U0056 G1M36U0057 G1M36U0058 G1M36U0059 G1M36U0060 G1M36U0061 G1M36U0062 G1M36U0063 G1M36U0065 G1M36U0066 G1M36U0067 G1M36U0068 G1M36U0069 G1M36U0070 G1M36U0071 G1M36U0072 G1M36U0073 G1M36U0074 G1M36U0075 G1M36U0076 G1M36U0077 G1M36U0078 G1M36U0079 G1M36U0080 G1M36U0081 G1M36U0082 G1M36U0083 G1M36U0085 G1M36U0086 G1M36U0087 G1M36U0088 G1M36U0089 G1M36U0090 G1M36U0091 G1M36U0093 G1M36U0094 G1M36U0095 G1M36U0096 G1M36U0097 G1M36U0098 G1M36U0099 G1M40W0204 G1M40W0205 G1M40W0206 G1M40W0210 G1M40W0211 G1M40W0212 G1M40W0213 G1M40W0214 G1M40W0215 G1M40W0216 G1M40W0217 G1M40W0218 G1M40W0219 G1M40W0220 G1M40W0221 G1M40W0222 G1M40W0223 G1M40W0224 G1M40W0225 G1M40W0226 G1M40W0227 G1M40W0228 G1M40W0229 G1M40W0230 G1M40W0231 G1M40W0232 G1M40W0233 G1M40W0234 G1M40W0235 G1M40W0237 G1M40W0238 G1M40W0239 G1M40W0240 G1M40W0241 G1M40W0242 G1M40W0243 G1M40W0244 G1M40W0245 G1M40W0246 G1M40W0247 G1M40W0248 G1M40W0249 G1M40W0250 G1M40W0251 G1M40W0252 G1M40W0253 G1M40W0254 G1M40W0255 G1M40W0256 G1M40W0257 G1M40W0258 G1M40W0259 G1M40W0260 G1M40W0261 G1M40W0262 G1M40W0263 G1M40W0264 G1M40W0265 G1M40W0266 G1M40W0267 G1M40W0271 G1M40W0272 G1M40W0273 G1M40W0274 G1M40W0276 G1M40W0277 G1M40W0278 G1M40W0279 G1M40W0280 G1M40W0281 G1M40W0282 G1M40W0283 G1M40W0284 G1M40W0285 G1M40W0286 G1M40W0287 G1M40W0288 G1M40W0289 G1M40W0291 G1M40W0292 G1M40W0293 G1M40W0294 G1M40W0295 G1M40W0296 G1M40W0297 G1M40W0298 G1M40W0299 G1M40W0300 G1M40W0301 G1M40W0302 G1M40W0303 G1M40W0304 G1M40W0305 G1M40W0306 G1M40W0307 G1M40W0308 G1M40W0309 G1M40W0310 G1M40W0311 G1M40W0312 G1M40W0313 G1M40W0314 G1M40W0315 G1M40W0316 G1M40W0317 G1M40W0318 G1M40W0319 G1M40W0320 G1M40W0321 G1M40W0322 G1M40W0329 G1M40W0330 G1M40W0331 G1M40W0332 G1M40W0333 G1M40W0334 G1M40W0335 G1M40W0336 G1M40W0338 G1M40W0339 G1M40W0340 G1M40W0341 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G1M40W0442 G1M40W0443 G1M40W0444 G1M40W0445 G1M40W0446 G1M40W0447 G1M40W0448 G1M40W0449 G1M40W0450 G1M40W0451 G1M40W0452 G1M40W0453 G1M40W0454 G1M40W0455 G1M40W0456 G1M40W0457 G1M40W0458 G1M40W0459 G1M40W0460 G1M40W0461 G1M40W0462 G1M40W0463 G1M40W0465 G1M40W0466 G1M40W0467 G1M40W0468 G1M40W0469 G1M40W0470 G1M40W0471 G1M40W0472 G1M40W0473 G1M40W0474 G1M40W0475 G1M40W0476 G1M40W0477 G1M40W0478 G1M40W0479 G1M40W0480 G1M40W0481 G1M40W0482 G1M40W0483 G1M40W0484 G1M40W0485 G1M40W0486 G1M40W0487 G1M40W0488 G1M40W0489 G1M40W0490 G1M40W0491 G1M40W0492 G1M40W0493 G1M40W0494 G1M40W0496 G1M40W0497 G1M40W0498 G1M40W0499 G1M40W0500 G1M40X0002 G1M40X0003 G1M40X0004 G1M40X0005 G1M40X0006 G1M40X0007 G1M40X0008 G1M40X0009 G1M40X0010 G1M40X0011 G1M40X0012 G1M40X0013 G1M40X0014 G1M40X0015 G1M40X0016 G1M40X0017 G1M40X0018 G1M40X0019 G1M40X0020 G1M40X0021 G1M40X0022 G1M40X0023 G1M40X0024 G1M40X0025 G1M40X0026 G1M40X0027 G1M40X0028 G1M40X0029 G1M40X0030 G1M40X0031 G1M40X0032 G1M40X0033 G1M40X0034 G1M40X0035 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製造販売業者等名称
製造販売業者の名称 ： 株式会社ＣＵ 製造販売業者の所在地： 東京都港区虎ノ門一丁目２番１０号虎ノ門桜田通ビル８Ｆ 許可の種類 ： 第一種医療機器製造販売業 許可番号 ： 13B1X10153 改修の原因となった製造所の名称、所在地、許可（認定）年月日及び許可（認定）番号 名称：CU Medical Systems,Inc 所在地：130-1,Dongwhagongdan-ro,Munmak-eup,Wonju-si,Gangwon-do,Korea 認定年月日：平成２５年１０月２１日 認定番号 ：BG10300125
改修理由
（１）経緯 市場より、バッテリの不具合によりバッテリパックの電圧が不安定になりAEDの状態を示すステータス インジケータが不安定な表示となり正常である〇表示から×表示になったり、また同時にバッテリ残量を示す インジケータがフル表示からゼロ表示になったり電源ボタンを押すとバッテリ残量不足のエラーになったりす る事象が報告されました。 （２）不具合の原因 外部委託業者が製造したバッテリパックにおいて、前工程を委託した特定の業者の製造上の問題があり、特定 ロットの一部にバッテリパックの早期消耗、枯渇、不安定な電圧といった事象が発生いたしました。 （３）改修範囲（対象ロット番号「製造番号・記号」）の特定理由 外部委託業者が製造したバッテリパックにおいて特定の前工程加工業者に依頼したロットのみの事象である ことを特定しています。 バッテリパックのロット： 頭4桁が以下のものです。 GM37,GM38,GM39,GM40,GM43,GM44,GM45,GM49
危惧される具体的な健康被害
バッテリパックが1日で枯渇することはなく取扱説明書やAEDに同梱されている「AEDの安全管理の手引き」に記 載されておりますステータスインジケータを日々見ることにより不具合が確認できます。そのため重篤な健康被 害が発生する可能性はないと考えております。また現在まで本件に起因する健康被害の発生の報告は受けており ません。
改修開始年月日
平成30年2月16日 情報提供の開始
効能・効果又は用途等
本品は、心電図（ＥＣＧ）を解析して、除細動ショックの要否を判定できる装置で、ＥＣＧの監視と除細動放電 の両方に機能する粘着性の除細動電極を介して傷病者に装着される。本品ではショックを供給すべき時点を操作 者に知らせる。本品は、急性心停止、（ＳＣＡ）の原因とされている心室細動（ＶＦ）/心室頻拍（ＶＴ）の除 細動を目的としており、(1)意識がなく、(2)正常呼吸が認められない急性心停止（ＳＣＡ）を呈する場合に、除 細動ショックを与えることで効果的な心機能の回復が期待できる。
その他
全出荷先を把握しています。
担当者及び連絡先
担当者 ： 医療機器品質保証部 藤本 好宏 連絡先 ： 東京都港区虎ノ門一丁目２番１０号虎ノ門桜田通ビル８Ｆ 株式会社ＣＵ 電話番号： 03-6205-7385 FAX番号 ： 03-6205-7386