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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUMMIT INDUSTRIES, LLCFLOOR MOUNTED TUBE STAND892.1770

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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 F)
SUMMIT INDUSTRIES, LLC
chicago IL
Manufacturer (Section D)
SUMMIT INDUSTRIES, LLC
chicago IL
Manufacturer (Section G)
Manufacturer Contact
william engel
2901 west lawrence ave.
chicago , IL 60625
(773) 353 -4030
Device Event Key2797953
MDR Report Key2764801
Event Key2661397
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
1 Patient Was 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
OTHER Device ID NumberNI
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer08/31/2012
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? 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
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 09/24/2012 Patient Sequence Number: 1
#TreatmentTreatment Date
NI
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