MAUDE Adverse Event Report: MICHIGAN INSTRUMENTS, INC LIFE-STAT; EXTERNAL CARDIAC COMPRESSOR

Model Number 1008

Device Problem Device Inoperable (1663)

Patient Problem Heart Failure (2206)

Event Date 09/07/2016

Event Type  malfunction  

Manufacturer Narrative

This device was not returned.The problem was determined to be a valve (igor) that failed, causing the unit to stop.It appears that the internal spool became stuck due to contamination or inadequate lubrication which prevented the unit from functioning.A new valve was supplied to our service facility in (b)(4) and the device was repaired there.The failed valve is being returned to us and will be evaluated upon receipt.

Event Description

The device was applied to a patient and performing cardiopulmonary resuscitation.It was reported that after 10 minutes the unit suddenly stopped with the piston in the down position.The device was removed from the patient and manual cpr was continued.The patient was not revived.

• Brand Name: LIFE-STAT
• 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: 7333573
• MDR Text Key: 102339786
• Report Number: 1821850-2016-00008
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• PMA/PMN Number: K073079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Emergency Medical Technician
• Device Model Number: 1008
• Device Catalogue Number: 16000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 8 MO
• 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
• Patient Age: 53 YR
• Patient Weight: 54