MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2000-07-10 for TMS HELAX-TMS VERSION 5.1 manufactured by Helax Ab.
[186463]
It was reported that an incorrect dose is calculated when using collapsed cone for certain beam angles.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8022247-2000-00005 |
| MDR Report Key | 285736 |
| Report Source | 06 |
| Date Received | 2000-07-10 |
| Date of Report | 2000-06-27 |
| Date of Event | 2000-06-08 |
| Date Mfgr Received | 2000-06-08 |
| Device Manufacturer Date | 1999-12-01 |
| Date Added to Maude | 2000-07-18 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MR. ROSS KACHANIWSKY |
| Manufacturer Street | 447 MARCH ROAD |
| Manufacturer City | KANATA, ONTARIO K2K 1X8 |
| Manufacturer Country | CA |
| Manufacturer Postal | K2K 1X8 |
| Manufacturer Phone | 5922790 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TMS |
| Generic Name | RADIATION TREATMENT PLANNING SYSTEM |
| Product Code | MVJ |
| Date Received | 2000-07-10 |
| Model Number | TMS |
| Catalog Number | HELAX-TMS VERSION 5.1 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 276506 |
| Manufacturer | HELAX AB |
| Manufacturer Address | BOX 1704 UPPSALA SW SE-751 47 |
| Baseline Brand Name | TMS |
| Baseline Model No | TMS |
| Baseline Catalog No | HELAX - TMS VERSION 5.1 |
| Baseline Device Family | TMS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K993766 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-07-10 |