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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUMMIT INDUSTRIES, LLC FLOOR MOUNTED TUBE STAND 892.1770

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SUMMIT INDUSTRIES, LLC FLOOR MOUNTED TUBE STAND 892.1770 Back to Search Results
Model Number J700
Event Date 08/27/2012
Event Type  Malfunction  
Manufacturer Narrative

Eval summary: insufficient welding. This event appears to be an isolated incident of insufficient welding. A replacement device has been installed at the user facility.

 
Event Description

The tube arm of an eight year old tube stand separated from it's tube column. A pt was positioned for an extremity exam at the time of the event. Reported info is that the pt received no injuries.

 
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Brand NameFLOOR MOUNTED TUBE STAND
Type of Device892.1770
Manufacturer (Section D)
SUMMIT INDUSTRIES, LLC
chicago IL
Manufacturer Contact
william engel
2901 west lawrence ave.
chicago , IL 60625
(773) 773 -7733
77335340 7733534030
MDR Report Key2764801
Report Number1450503-2012-00001
Device Sequence Number1
Product CodeIXY
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 09/26/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/24/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberJ700
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer08/31/2012
Is The Reporter A Health Professional? No
Date Manufacturer Received08/28/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2004
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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