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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 04/14/2017
Event Type  Malfunction  
Manufacturer Narrative

Device arrived in good condition. The customer complaint of no compressions was confirmed, as well as the sound of leaking air. There was a noticable rattle coming from inside the covers. The unit arrived with no lip valve or pdv cover and the screw for the arm lock handle was also missing. The covers were removed to evaluate the rattling noise and it was discovered that a blank hose fitting from the cdnv valve had loosened and come out of its fixture. This allowed all of the gas to escape before enterring the system causing the failure to compress. The fitting was replaced and the device functioned properly to all of its' specifications.

 
Event Description

The device was applied to a female patient in cardiac arrest. It was reported that the unit was in use for well over 20 minutes without any complications or issues. Without any notice the unit stopped compressing. The operators checked batteries and connections but were not able to get the unit to work. The unit was removed from the patient and manual cpr was continued. It is not known if the patient was ultimately 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 Key7333558
MDR Text Key102340616
Report Number1821850-2017-00001
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 HEALTH PROFESSIONAL,USER FACI
Remedial Action Repair
Type of Report Initial
Report Date 05/09/2017
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 EMERGENCY MEDICAL TECHNICIAN
Device MODEL Number1008
Device Catalogue Number16000
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/19/2017
Was the Report Sent to FDA? No
Device Age1 yr
Event Location No Information
Date Manufacturer Received04/19/2017
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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