Recall Z-1632-2018— Michigan Instruments, Inc.
Class III · Terminated
Class III FDA medical device recall by Michigan Instruments, Inc., initiated 2018-02-13, terminated 2019-04-03. It names one FDA 510(k) clearance: K972525. 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.. Reason: 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..
- Recalling firm
- Michigan Instruments, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2018-02-13
- Terminated
- 2019-04-03
- Firm location
- Grand Rapids, MI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.