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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 05/27/2017
Event Type  Malfunction  
Manufacturer Narrative

This failure was reported to us by the distributor, however, the device was not returned. We have, therefore, not been able to evaluate or test the unit to determine the reason for this incident. It is currently in service and no additional problems have been reported.

 
Event Description

The device was applied to a male patient in cardiac arrest. It was reported that after ten minutes of use the the unit suddenly stopped. The unit was removed from the patient and manual cardiopulmonary resuscitation was continued. The patient was not revived. The user stated that the failure did not contribute to the death of the patient.

 
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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 Key7333567
MDR Text Key102342248
Report Number1821850-2017-00007
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,FOREIGN,HEALTH PR
Type of Report Initial
Report Date 06/27/2017
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
Device MODEL Number1008
Device Catalogue Number16000
Was Device Available For Evaluation? No
Was the Report Sent to FDA? No
Device Age6 yr
Event Location No Information
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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