MAUDE Adverse Event Report: MICHIGAN INSTRUMENTS, INC THUMPER MODEL 1007CC; EXTERNAL CARDIAC COMPRESSOR

Model Number 1007CC

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Date 05/08/2015

Event Type  malfunction  

Event Description

A patient (a groundskeeper that worked alone) was found in a yard non-responsive.It was unknown how long the patient had been down.The device was applied to the patient to attempt resuscitation.It was reported that during the resuscitation attempt a leaking noise was heard from the device and the compression depth control did not work properly.The device was removed and manual chest compressions were continued.The patient was not revived.The shift supervisor stated that: "the patient was non-viable, but they went through with the resuscitation protocol anyway." the failure of the equipment did not contribute to the outcome.

Manufacturer Narrative

A complete evaluation of this device was performed.It was found that there was tape around the oxygen supply input hose.Our examination found that the oxygen supply hose had been cut by a bushing that is used to fasten the hose to the fitting.This is typically caused by carrying or lifting the device by the hose.It was also discovered that the chest depth compression knob set screw had loosened and was allowing the knob to spin around the shaft of the depth compression assembly.This was the cause of the problem with setting the proper compression depth that was reported.

• Brand Name: THUMPER MODEL 1007CC
• 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: joe baldwin ; 4717 talon ct. se; grand rapids, MI 49512
• MDR Report Key: 4827729
• MDR Text Key: 5903550
• Report Number: 1821850-2015-00004
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Paramedic
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 06/09/2015

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: Paramedic
• Device Model Number: 1007CC
• Device Catalogue Number: 15350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2015
• Is the Reporter a Health Professional?: Yes
• Device Age: 2 YR
• Initial Date Manufacturer Received: 05/18/2015
• Initial Date FDA Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2013
• 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