MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-13 for HDR BRACHTHERAPY SYSTEM 11731 manufactured by Elekta, Inc..
[110916064]
Patient Sequence No: 1, Text Type: N, H10
[110916067]
A required software upgrade for the treatment control station (tcs) of the hdr ir-192 brachytherapy system was performed by the service engineer from elekta/nucletron, inc. After completing the upgrade, the engineer informed that all prior patient treatments were transferred. Upon using the hdr system 4 days later for treating the patient, there was confusion as to how many treatment fractions had been delivered. Apparently, her treatment had not been transferred during the tcs software upgrade, and it appeared she only had received 3 treatment fractions instead of 4. Examining the departmental record of treatment delivery, it was clear that 4 treatments had been delivered and that the tcs record was not up-to-date. Therefore, the patient's 5th (and final) treatment fraction was properly delivered 4 days post upgrade. The tcs manufacturer and engineer were contacted by the reporter to alert them of the issue. This was logged with elekta. Elekta responded early the following month that this issue had not been previously reported, and that their procedures for tcs upgrade are sufficient. This event was logged soon after the safety meeting that morning.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7595874 |
| MDR Report Key | 7595874 |
| Date Received | 2018-06-13 |
| Date of Report | 2018-05-22 |
| Date of Event | 2018-04-20 |
| Report Date | 2018-05-22 |
| Date Reported to FDA | 2018-05-22 |
| Date Reported to Mfgr | 2018-05-22 |
| Date Added to Maude | 2018-06-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HDR BRACHTHERAPY SYSTEM |
| Generic Name | SOURCE, BRACHYTHERAPY, RADIONUCLIDE |
| Product Code | KXK |
| Date Received | 2018-06-13 |
| Model Number | 11731 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELEKTA, INC. |
| Manufacturer Address | 400 PERIMETER CENTER TERRANCE NE SUITE 50 ATLANTA GA 30346 US 30346 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-13 |