MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-21 for GAMMABEAM 100 80 manufactured by Best Theratronics Ltd..
[22658666]
The source could not be returned to the shielded position because a screw had fallen into the source drawer, causing it to become jammed. The screw had fallen out of the jaw adjuster rod coupling and into the source chamber when the gantry was at 180 degrees. The jaw adjuster knob can only be installed after the covers are installed. The setscrew may not have been securely fastened on a subsequent service visit that required the covers to be removed. The operator normally observes both the unit and the patient at all times during treatment. Should the source remain in the exposed position at the end of treatment, the fact would be readily noticed by the operator and the patient evacuated from the room. Labeling for the device instructs the operator on the steps to be followed in the event that a source remains in the exposed position at the end of treatment.
Patient Sequence No: 1, Text Type: N, H10
[22658667]
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 safely removed from the room.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006946288-2015-00001 |
| MDR Report Key | 4950227 |
| Date Received | 2015-07-21 |
| Date Mfgr Received | 2015-07-02 |
| Device Manufacturer Date | 2014-09-01 |
| Date Added to Maude | 2015-07-29 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | 0 |
| Brand Name | GAMMABEAM 100 |
| Generic Name | COBALT THERAPY |
| Product Code | IWB |
| Date Received | 2015-07-21 |
| Model Number | 80 |
| 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 | 2015-07-21 |