MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-09-25 for MICROSELECTRON MHDR DIGITAL manufactured by Nucletron.
[4837616]
Information derived from the nrc report: the user planned the treatment time to 168 seconds for the associated source strength. The software calculated the treatment time (300 seconds) for the current source strength. The prescribed dose of 600 cgy for that fraction was higher than the user intended and this was not noticed by the user.
Patient Sequence No: 1, Text Type: D, B5
[12206430]
This is the manufacturer's final report. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611894-2014-00002 |
| MDR Report Key | 4116580 |
| Report Source | 00 |
| Date Received | 2014-09-25 |
| Date of Report | 2014-09-25 |
| Date of Event | 2014-08-29 |
| Date Mfgr Received | 2014-08-28 |
| Date Added to Maude | 2014-09-25 |
| 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 Street | LINAC HOUSE FLEMING WAY |
| Manufacturer City | CRAWLEY, WEST SUSSEX RH109RR |
| Manufacturer Country | UK |
| Manufacturer Postal | RH10 9RR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROSELECTRON MHDR DIGITAL |
| Generic Name | SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED |
| Product Code | JAQ |
| Date Received | 2014-09-25 |
| Model Number | DIGITAL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUCLETRON |
| Manufacturer Address | WAARDGELDER 1 VEENENDAAL, NL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-09-25 |