medical Class III Updated 2018-05-16

Michigan Instruments, Inc. recalls Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog

Recalled Product

Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product Usage: The device is used to perform Cardiopulmonary Resuscitation (CRP) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.

Hazard / Issue

A performance issue with the chest depth needle valve (CDNV) may arise where turning the knob will not deliver any compression depth to the piston during the first 5 revolutions of the knob.The last ¿ to ¿ revolution of the knob could deliver a full 8cm of compression.

Issued by

FDA

Distribution: Distributed to China.
Lot/Code Info: CDNV - SN Installed In - Mfr Date 5519 CCV-2181 09/17 5518 CCV-2182 09/17 5516 CCV-2183 09/17 5517 CCV-2184 09/17 5522 CCV-2196 09/17 5531 CCV-2200 12/17 5533 CCV-2201 12/17 5538 CCV-2202 12/17 5524 CCV-2203 12/17 5523 CCV-2204 12/17 5526 CCV-2205 12/17 5528 CCV-2206 12/17 5529 CCV-2208 12/17 5535 CCV-2209 12/17 5530 CCV-2210 12/17 5534 CCV-2211 12/17 5539 CCV-2212 12/17 5520 CCV-2213 12/17 5532 CCV-2214 12/17 5525 CCV-2215 12/17 5536 CCV-2216 12/17 5537 CCV-2217 12/17 5521 CCV-2218 12/17 5527 CCV-2219 12/17 5541 CCV-2220 01/18 5550 CCV-2221 01/18 5546 CCV-2222 01/18 5544 CCV-2223 01/18 5543 CCV-2224 01/18 5542 CCV-2225 01/18 5553 CCV-2226 01/18 5547 CCV-2228 01/18 5549 CCV-2229 01/18 5548 CCV-2230 01/18 5545 CCV-2231 01/18 5540 CCV-2232 01/18 5555 CCV-2233 01/18 5554 CCV-2237 01/18
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