MAUDE Adverse Event Report: MICHIGAN INSTRUMENTS, INC THUMPER; EXTERNAL CARDIAC COMPRESSOR

Model Number	1007CC
Health Effect - Clinical Code	Heart Failure (2206)
Date of Event	10/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer complaint that the compression depth knob turned freely was confirmed.The knob is locked on a shaft using a set screw.It was apparent that the knob had been turned with excessive force which broke the set screw free from the shaft.This allowed the knob to turn without activating the compression depth adjustment.The unit has been repaired and returned to the customer.
Event or Problem Description
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.

• Brand Name: THUMPER
• Common Device Name: EXTERNAL CARDIAC COMPRESSOR
• Manufacturer (Section D): MICHIGAN INSTRUMENTS, INC; 4717 talon ct. se; grand rapids MI 49512
• MDR Report Key: 7333552
• Report Number: 1821850-2017-00014
• Device Sequence Number: 10767282
• Product Code: DRM
• UDI-Device Identifier: 00860682000107
• UDI-Public: (01)00860682000107(11)160928
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K851139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Paramedic
• Device Model Number: 1007CC
• Device Catalogue Number: 15350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Was the Report Sent to FDA?: No
• Device Age: 1 YR
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 181