MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-01-17 for CHIROTECH MODULAR CHIROPRACTIC SYSTEM CHIROTECH-0053 manufactured by Summit Industries, Inc..
[813764]
Structure was positioned vertically for an extremity exposure, and was left in that position after procedure was completed. A few mins later, the receptor extension fell to the floor and separated completely from the structure, causing the carriage to rise and counterweight to drop.
Patient Sequence No: 1, Text Type: D, B5
[8041156]
Summit's dealer, x-ray sales & svc (xrs), was notified by the end user (eu) that the horizontal slide assembly, "fell to the floor and separated completely from the structure, causing the carriage to rise and counterweight to drop". Xrs svc person went to site and verified the situation and tagged out the equipment and told dr not to use it.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1450503-2008-00001 |
| MDR Report Key | 982970 |
| Report Source | 07 |
| Date Received | 2008-01-17 |
| Date of Report | 2008-01-17 |
| Date of Event | 2008-01-10 |
| Date Mfgr Received | 2008-01-10 |
| Device Manufacturer Date | 1999-04-30 |
| Date Added to Maude | 2008-10-16 |
| 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 | DON MATSON |
| Manufacturer Street | 2901 WEST LAWRENCE AVE. |
| Manufacturer City | CHICAGO IL 60625 |
| Manufacturer Country | US |
| Manufacturer Postal | 60625 |
| Manufacturer Phone | 7733534032 |
| Single Use | 0 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHIROTECH MODULAR CHIROPRACTIC SYSTEM |
| Generic Name | IXY HOLDER, RADIOGRAPHIC CASSETTE, WALL-MOUNTED |
| Product Code | IXY |
| Date Received | 2008-01-17 |
| Model Number | CHIROTECH-0053 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 987258 |
| Manufacturer | SUMMIT INDUSTRIES, INC. |
| Manufacturer Address | CHICAGO IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-17 |