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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 07/30/2017
Event Type  Malfunction  
Manufacturer Narrative

This unit was returned to the factory and was extensively evaluated. After many hours of testing the compalint could not be confirmed. Is was noted that this unit has never received recomended factory service and has been used beyond its' expected service life without this recommended maintenance. The unit will be serviced and updated and returned to the customer.

 
Event Description

The device was applied to a patient in cardiac arrest. It was reported that after 30 minutes of use compressions suddenly stopped. The unit was removed from the patient and manual cpr continued. The unit was able to be restarted. 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 Key7333560
MDR Text Key102340931
Report Number1821850-2017-00011
Device Sequence Number1
Product Code DRM
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK073079
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Remedial Action Repair
Type of Report Initial
Report Date 09/12/2017
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? Device Returned To Manufacturer
Date Returned to Manufacturer08/14/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Age2 yr
Event Location Hospital
Date Manufacturer Received08/14/2017
Was Device Evaluated By Manufacturer? Yes
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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