MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-03-09 for THERATRON ELITE 100 G210 manufactured by Best Theratronics Ltd..
[1123676]
A report was received that the source failed to return to the fully shielded position at the end of a patient treatment. The patient was removed from the room and the source was manually returned to the safe position.
Patient Sequence No: 1, Text Type: D, B5
[8140369]
The operator normally observes both the unit and patient at all times during a treatment. Should the source remain in the exposed or partially exposed position at the end of a treatment, the fact would be readily noticed by the operator and the patient evacuated from the room. Labelling for the device instructs the operator on the steps to be followed in the event that the source remains on at the end of a 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 | 3006946288-2009-00001 |
| MDR Report Key | 1381426 |
| Report Source | 05,06 |
| Date Received | 2009-03-09 |
| Date of Report | 2009-03-03 |
| Date of Event | 2009-02-03 |
| Date Mfgr Received | 2009-02-12 |
| Device Manufacturer Date | 2000-10-01 |
| Date Added to Maude | 2010-01-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 6135912100 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERATRON |
| Generic Name | COBALT THERAPY |
| Product Code | IWD |
| Date Received | 2009-03-09 |
| Model Number | ELITE 100 |
| Catalog Number | G210 |
| 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 CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-03-09 |