MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2003-09-10 for THERATRON T780 G22 manufactured by Mds Nordion.
[302590]
A report was received that a collision occurred between the gantry arm of the unit and the pt treatment table. There was no report of injury to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8022247-2003-00018 |
| MDR Report Key | 484923 |
| Report Source | 01,05 |
| Date Received | 2003-09-10 |
| Date of Event | 2003-08-08 |
| Date Mfgr Received | 2003-08-08 |
| Device Manufacturer Date | 1982-03-01 |
| Date Added to Maude | 2003-09-26 |
| 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 | E. MARTELL |
| Manufacturer Street | 447 MARCH ROAD |
| Manufacturer City | KANATA, ONTARIO |
| Manufacturer Country | CA |
| Manufacturer Phone | 5922790 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERATRON |
| Generic Name | COBALT TELETHERAPY DEVICE |
| Product Code | IWD |
| Date Received | 2003-09-10 |
| Model Number | T780 |
| Catalog Number | G22 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 473816 |
| Manufacturer | MDS NORDION |
| Manufacturer Address | 447 MARCH RD. KANATA, ONTARIO * K2K 1X8 |
| Baseline Brand Name | THERATRON |
| Baseline Generic Name | COBALT TELETHERAPY DEVICE |
| Baseline Model No | T780 |
| Baseline Catalog No | G22 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-09-10 |