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U.S. Department of Health and Human Services

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

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MICHIGAN INSTRUMENTS, INC LIFE-STAT EXTERNAL CARDIAC COMPRESSOR Back to Search Results
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.

 
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Brand NameLIFE-STAT
Type of DeviceEXTERNAL 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 Key7333573
MDR Text Key102339786
Report Number1821850-2016-00008
Device Sequence Number1
Product Code DRM
Combination Product (Y/N)N
PMA/PMN NumberK073079
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received03/13/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator EMERGENCY MEDICAL TECHNICIAN
Device MODEL Number1008
Device Catalogue Number16000
Was Device Available For Evaluation? No
Was the Report Sent to FDA? No
Device Age8 mo
Event Location No Information
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/23/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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