MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2009-01-07 for FINAL ASSY, DR1000 BUCKY TRAY 251007 manufactured by Liebel - Flarsheim Co..
[1021856]
Customer report the grid drive encoder rubs against the optical sensor over time causing grid drive speed changes, in turn, causes image artifacts. (b) (4) says they have to go in and clean off all of the residue from the sensor that seems to solve the problem.
Patient Sequence No: 1, Text Type: D, B5
[8207258]
Liebel flarsheim manufacturing report: l f product engineer discussed with the electrical design engineer the effects of the grid homing flag touching the sensor. The conclusion was that this sensor has nothing to do with grid speed. Speed is controlled by the motor encoder; it could only effect grid home position if any. This is the first time we have heard of this problem in over (3) years production. Possible issue could be the centering of the home position flag. Product engineer will follow the assembly operation the next time units are built and observe the centering of the home position flag. If centering of the home position flag is identified as the potential problem, then adjustments to the process will be addressed at that time as required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2008-00076 |
| MDR Report Key | 1279079 |
| Report Source | 06,08 |
| Date Received | 2009-01-07 |
| Date of Report | 2004-10-22 |
| Date Mfgr Received | 2004-10-22 |
| Date Added to Maude | 2009-12-09 |
| 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 | DAVID BENSON |
| Manufacturer Street | 2111 EAST GALBRAITH RD |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Manufacturer Phone | 5139485719 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FINAL ASSY, DR1000 |
| Generic Name | BUCKY TRAY |
| Product Code | ITY |
| Date Received | 2009-01-07 |
| Model Number | BUCKY TRAY |
| Catalog Number | 251007 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL - FLARSHEIM CO. |
| Manufacturer Address | 2111 E GALBRAITH RD CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-01-07 |