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 2014-05-13 for THERATRON PHOENIX manufactured by Best Theratronics Ltd..
[4409096]
A report was rec'd that the radioactive source failed to fully return to shielded position at the end of the pt treatment. The source was only one inch away from being fully shielded. The pt was removed and the treatment room was deemed to be safe.
Patient Sequence No: 1, Text Type: D, B5
[11962843]
Based on the customer's description and details from best theratronic's last visit ((b)(6) 2012 source change), the problem seems to be normal wear and tear of the air system and switches. This unit has been in use for 21 yrs and is beyond the useful life of 18 yrs for this device. Best theratronics recommends a pmi every 5 yrs as per the operator manual however, the customer has not requested any service by best theratronics.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006946288-2014-00002 |
| MDR Report Key | 3848672 |
| Report Source | 01,05,06 |
| Date Received | 2014-05-13 |
| Date of Report | 2014-03-14 |
| Date of Event | 2014-02-19 |
| Date Mfgr Received | 2014-02-19 |
| Device Manufacturer Date | 1992-12-01 |
| Date Added to Maude | 2014-06-25 |
| 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 VAN DER SCHUEREN |
| Manufacturer Street | 413 MARCH ROAD |
| Manufacturer City | OTTAWA, ONTARIO K2K 0E4 |
| 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 | 2014-05-13 |
| Model Number | PHOENIX |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-13 |