FDA Adverse Event
Malfunction
Summary report: N
CHIROTECH MODULAR CHIROPRACTIC SYSTEM
MDR report key: 982970
·
Received January 17, 2008
Report
- Report Number
- 1450503-2008-00001
- Event Type
- Malfunction
- Date Received
- January 17, 2008
- Date of Event
- January 10, 2008
- Report Date
- January 17, 2008
- Manufacturer
- SUMMIT INDUSTRIES, INC.
- Product Code
- IXY
- PMA / PMN Number
- K851440
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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.
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CHIROTECH MODULAR CHIROPRACTIC SYSTEM | IXY HOLDER, RADIOGRAPHIC CASSETTE, WALL-MOUNTED | IXY | SUMMIT INDUSTRIES, INC. | CHIROTECH-0053 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |