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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 1007CC
Device Problems Device Inoperable (1663); Failure to Shut Off (2939)
Patient Problem Heart Failure (2206)
Event Date 10/04/2017
Event Type  Malfunction  
Manufacturer Narrative

Device arrived in good condition. There were no signs of any damage to the device. The customer complaint that the device would not shut off could not be confirmed. Upon the initial evaluation the compressor could be heard turning on and off when the switch was turned. When the depth compression knob the device began to compress, the on/off switch was turned to off and the compression stopped. The front cover was taken off the device to examine the on/off switch but there is no damage to the assembly. Long term testing was not able to reproduce the complaint. Unit was returned to the customer.

 
Event Description

It was reported that the device was used to perform cpr on a patient for about 30 minutes. The patient was not revived but when attempting to remove the device, it would not shut off. The oxygen hose was disconnected which stopped the unit. It was stated that the problem did not contribute to the failure to revive 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 Key7333564
MDR Text Key102458461
Report Number1821850-2017-00013
Device Sequence Number1
Product Code DRM
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK851139
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Remedial Action Repair
Type of Report Initial
Report Date 11/01/2017
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 PARAMEDIC
Device MODEL Number1007CC
Device Catalogue Number15350
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/16/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Device Age1 yr
Event Location No Information
Date Manufacturer Received10/16/2017
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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