FDA-Device2018-05-16Class III

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.

Michigan Instruments, Inc.
Hazard

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.

Sold states
Distributed to China.
Affected count
38 devices
Manufactured in
4717 Talon Ct SE, N/A, Grand Rapids, MI, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1632-2018

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