Thumper 1007CCMIIRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00860682000107), received between Mar 13, 2018 and Mar 13, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Inoperable” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K972525); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2018Device Inoperable; Failure to Shut Off

  IT WAS REPORTED THAT THE DEVICE WAS USED TO PERFORM CPR ON A PATIENT FOR ABOUT 30 MINUTES. THE PATIENT WAS NOT REVIVED BUT WHEN ATTEMPTING TO REMOVE THE DEVICE, IT WOULD NOT SHUT OFF. THE OXYGEN HOSE WAS DISCONNECTED WHICH STOPPED THE UNIT. IT WAS STATED THAT THE PROBLEM DID NOT CONTRIBUTE TO THE FAILURE TO REVIVE THE PATIENT.

  Patient problems: Heart Failure

  MAUDE report 7333564 ↗
• MalfunctionMar 13, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE DEVICE WAS APPLIED TO A PATIENT TO PERFORM CPR. WHEN ATTEMPING TO ADJUST THE COMPRESSION DEPTH, THE KNOB TURNED FREELY WHICH DID NOT ALLOW THE COMPRESSION DEPTH TO BE PROPERLY ADJUSTED. THE DEVICE WAS REMOVED FROM THE PATIENT AND MANUAL CPR CONTINUED. THE PATIET WAS NOT REVIVED.

  Patient problems: Heart Failure

  MAUDE report 7333552 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K972525. One submission often covers many models, so check the product and lot details in each record.

• Z-1632-2018 · Feb 13, 2018 · Terminated
  Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product Usage: The device is used to perform Cardiopulmonary Resuscitation (CRP) on adult patients and only a
• Z-0178-2007 · Sep 14, 2006 · Terminated
  Michigan Instruments Thumper Mechanical CPR Device; Model 1007, Part number 15000.
• Z-0119-2007 · Aug 4, 2006 · Terminated
  Michigan Instruments Thumper Mechanical CPR Device; Model 1007.