Recall Z-1632-2018 ยท DRM Compressor, Cardiac, External
Michigan Instruments, Inc.
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.
| Date | Feb 13, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | The customer was notified via email on 2/13/18. The customer has been instructed to identify the location of the affected units (if distributed, make arrangements to have unit returned for service), perform the CDNV replacement (instructions will be provided), and test the device to the Final Test Procedure (TS190). The customer should also record on the provided spreadsheet the SN of the CDNV replaced in the CCV device, date of replacement. A column is provided to check-off indicating the device was tested and accepted to the Final Test Procedure (TS190). Return the completed spreadsheet |
| Quantity | 38 devices |
| Distribution | Distributed to China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972525 | THUMPER Michigan Instruments, Inc., Oct 2, 1997 |