MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-11-03 for RADSOURCE manufactured by Best Theratronics.
[1690345]
The routine dosimetry performed as part of the quality assurance program discovered that there was low x-ray radiation output at the top end of the canister. The unit was immediately taken out of service. This problem was not detected by the radiation indicator labels because these were placed near the bottom of the canister where the radiation dose was acceptable.
Patient Sequence No: 1, Text Type: D, B5
[8918246]
A review of the data and circumstances seems to indicate that the likely root cause was an incorrect signal being sent to the power supply, either because of a faulty control board or due to a damaged or corroded cable connection between the control board and power supply. The problem had gone undetected by the control system. After receiving a new power supply and cable, the unit performed as per specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006946288-2010-00002 |
| MDR Report Key | 1892598 |
| Report Source | 07 |
| Date Received | 2010-11-03 |
| Date of Report | 2010-07-13 |
| Date of Event | 2010-07-13 |
| Date Mfgr Received | 2010-07-13 |
| Date Added to Maude | 2012-01-12 |
| 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 | MIKE DE VAAN DER SCHUEREN |
| Manufacturer Street | 413 MARCH ROAD |
| Manufacturer City | OTTAWA, ONTARIO K2K 0E4 |
| Manufacturer Country | CA |
| Manufacturer Postal | K2K 0E4 |
| Manufacturer Phone | 5912100 |
| Single Use | 0 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RADSOURCE |
| Generic Name | IRRADIATOR, BLOOD TO PREVENT GRAFT VERS |
| Product Code | MOT |
| Date Received | 2010-11-03 |
| Model Number | RADSOURCE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEST THERATRONICS |
| Manufacturer Address | OTTAWA, ONTARIO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-03 |