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

Model Number 1007CC

Device Problem Break (1069)

Patient Problem Heart Failure (2206)

Event Date 10/07/2016

Event Type  malfunction  

Manufacturer Narrative

This device was not returned.The problem was a broken base.The unit is 14 years old and we have seen a few bases that have cracked or broken due to the stress of use over a long period of time.To avoid this possibility after long term use the base was strengthened several years ago.A new base was sent to the customer.

Event Description

The device was applied to a patient and performing cardiopulmonary resuscitation.It was reported that after 40 minutes the base of the unit broke.The device was removed from the patient and manual cpr was continued.The patient was not revived.The operator stated that the failure do not contribute in any way to the death.

• Brand Name: THUMPER
• Type of Device: EXTERNAL CARDIAC COMPRESSOR
• Manufacturer (Section D): MICHIGAN INSTRUMENTS, INC; 4717 talon ct. se; grand rapids MI 49512
• Manufacturer (Section G): MICHIGAN INSTRUMENTS, INC.; 4717 talon ct. se; grand rapids MI 49512
• Manufacturer Contact: jim maatman ; 4717 talon ct. se; grand rapids, MI 49512 ; 6165549696
• MDR Report Key: 7333555
• MDR Text Key: 102345277
• Report Number: 1821850-2016-00007
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• PMA/PMN Number: K972525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/03/2016

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
• Device Operator: Emergency Medical Technician
• Device Model Number: 1007CC
• Device Catalogue Number: 15350
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 14 YR
• Initial Date Manufacturer Received: 10/12/2016
• Initial Date FDA Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/23/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1