MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-09-24 for FLOOR MOUNTED TUBE STAND J700 manufactured by Summit Industries, Llc.
[2905543]
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.
Patient Sequence No: 1, Text Type: D, B5
[10140838]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1450503-2012-00001 |
| MDR Report Key | 2764801 |
| Report Source | 07 |
| Date Received | 2012-09-24 |
| Date of Report | 2012-09-26 |
| Date of Event | 2012-08-27 |
| Date Mfgr Received | 2012-08-28 |
| Device Manufacturer Date | 2004-04-01 |
| Date Added to Maude | 2013-01-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | WILLIAM ENGEL |
| Manufacturer Street | 2901 WEST LAWRENCE AVE. |
| Manufacturer City | CHICAGO IL 60625 |
| Manufacturer Country | US |
| Manufacturer Postal | 60625 |
| Manufacturer Phone | 7733534030 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLOOR MOUNTED TUBE STAND |
| Generic Name | 892.1770 |
| Product Code | IXY |
| Date Received | 2012-09-24 |
| Returned To Mfg | 2012-08-31 |
| Model Number | J700 |
| Catalog Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUMMIT INDUSTRIES, LLC |
| Manufacturer Address | CHICAGO IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-24 |