MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-01-15 for THERATRON EQUINOX manufactured by Best Theratronics Ltd.
[19022305]
A report was received that the radioactive source failed to return to the fully shielded position at the end of the pt treatment. The pt was removed from the room and the source was manually returned to the safe position.
Patient Sequence No: 1, Text Type: D, B5
[19273341]
Based on past experience it is likely that the cause was foreign material inside the collimator. This is typically rectified by rotating the gentry to the zero position so that any material will fall out. This is what was recommended by btl at the time that the event was reported. The customer subsequently reported that the source had been returned to the safe position and the unit was back in service. This unit has been in use for 7 years without any preventive maintenance performed by best theratronics. The recommended frequency is every 5 years as per the operator manual. The operator normally observes both the unit and the pt at all times during the treatment. Should the source remain in the exposed or partially exposed position at the end of treatment, this would be readily noticed by the operator and the pt evacuated from the room. In this event the collimator also automatically closes to reduce exposure to pt and/or operator. Labeling for the device instructs the operator on the steps to be followed in the event that the source remains in the exposed position at the end of treatment. The source can then be manually returned to the fully shielded position using the emergency return handle provided with the device. Use of the return handle is fully described in the operator's manual.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006946288-2014-00001 |
| MDR Report Key | 3793207 |
| Report Source | 01,05,06 |
| Date Received | 2014-01-15 |
| Date of Report | 2014-01-10 |
| Date of Event | 2013-12-24 |
| Date Mfgr Received | 2013-12-24 |
| Device Manufacturer Date | 2005-11-01 |
| Date Added to Maude | 2014-05-28 |
| 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 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERATRON |
| Generic Name | COBALT THERAPY |
| Product Code | IWB |
| Date Received | 2014-01-15 |
| Model Number | EQUINOX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEST THERATRONICS LTD |
| Manufacturer Address | OTTAWA, ONTARIO 0000 0000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-15 |