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 05/07/2017

Event Type  malfunction  

Manufacturer Narrative

The failure was a broken base.The device was not returned.A new base was sent to the customer.The broken base was returned and evaluated but there was no apparent reason that the bae broke.Additional analysis will be done.

Event Description

The device was applied to a female patient in cardiac arrest.It was reported that after four minutes of use the base broke.The unit was removed from the patient and manual cardiopulmonary resuscitation was continued.The patient was revived.

• 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: 7333568
• MDR Text Key: 102334618
• Report Number: 1821850-2017-00003
• 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: 05/17/2017

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
• 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: 2 YR
• Initial Date Manufacturer Received: 05/08/2017
• Initial Date FDA Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 64 YR