MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-01-07 for RAYCELL manufactured by Best Therataronics.
[18965178]
Best theratronics was performing a preventive maintenance inspection and discovered low x-ray output readings at 2 points inside the canister near the upper x-ray tube. All other points were within acceptable limits. The use of rad-sure 25 gy radiation indicator devices inside the canister did not detect the low output.
Patient Sequence No: 1, Text Type: D, B5
[19116224]
A leak from the coolant system (not provided by best theratronics) appears to have caused corrosion and leached inside the x-ray chamber. The corrosive material became deposited on the x-ray filter and partially blocked the beam. The cause of the leak is not known. This is the first report of this type of problem. Two other x-ray units at the same facility were inspected and found to have acceptable outputs. There was evidence of a previous small leak (drop) on one unit but no visible indications of corrosion that was seen on the original unit.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006946288-2010-00001 |
| MDR Report Key | 1577785 |
| Report Source | 07 |
| Date Received | 2010-01-07 |
| Date of Report | 2010-01-07 |
| Date of Event | 2009-12-04 |
| Date Mfgr Received | 2009-12-04 |
| Device Manufacturer Date | 2008-06-01 |
| Date Added to Maude | 2010-08-05 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MIKE DE VAN DER SCHUEREN, DIR |
| Manufacturer Street | 413 MARCH ROAD |
| Manufacturer City | OTTAWA, ONTARIO K2K 0E4 |
| Manufacturer Country | CA |
| Manufacturer Postal | K2K 0E4 |
| Manufacturer Phone | 5912100 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAYCELL |
| Generic Name | RAYCELL |
| Product Code | MOT |
| Date Received | 2010-01-07 |
| Model Number | RAYCELL |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEST THERATARONICS |
| Manufacturer Address | OTTAWA, ONTARIO CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-01-07 |