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

Model Number 1007CC

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Date 02/11/2018

Event Type  malfunction  

Manufacturer Narrative

Unit was returned and a complete evaluation was performed.Device operated normally initially then a slowing down of the compression rate was observed.Suspected cause of the problem was the turbin control valve which was replaced.After replacement, the device operated normally.Long term testing was done and proper operation was verified.The device was returned to the customer.

Event Description

It was reported that the device was being used on a patient to perform cpr.It was reported the device slowed down in compressions after over an hour of operation.A later communication relayed from the trauma rn was that the device slowed down after 4 hours of operation.Patient was not revived.It was the operator's opinion that the problem with the device did not contribute to the death of the patient.

• 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: matt maatman ; 4717 talon ct. se; grand rapids, MI 49512 ; 6165549696
• MDR Report Key: 7313297
• MDR Text Key: 101846461
• Report Number: 1821850-2018-00001
• 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: Repair
• Type of Report: Initial
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 1007CC
• Device Catalogue Number: 15350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Was the Report Sent to FDA?: No
• Device Age: 5 YR
• Date Manufacturer Received: 02/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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 Weight: 73