MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 1998-07-14 for THERATRON T780 G22 manufactured by Theratronics International Ltd.
[120604]
A service rep inspecting the cobalt therapy unit determined that it was in urgent need of repair. Errors in the optical distance indicator, collimator cross wire setting and the lack of brakes on the treatment table could result in serious treatment position errors although none were actually observed or reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610077-1998-00012 |
| MDR Report Key | 179562 |
| Report Source | 01,05,07 |
| Date Received | 1998-07-14 |
| Date of Report | 1998-07-13 |
| Date of Event | 1998-04-20 |
| Date Mfgr Received | 1998-04-20 |
| Device Manufacturer Date | 1997-03-01 |
| Date Added to Maude | 1998-07-31 |
| 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 | 3 |
| 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 | 1998-07-14 |
| Model Number | T780 |
| Catalog Number | G22 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 174599 |
| Manufacturer | THERATRONICS INTERNATIONAL LTD |
| Manufacturer Address | 413 MARCH RD P.O. BOX 13140 KANATA, ONTARIO CA |
| Baseline Brand Name | THERATRON |
| Baseline Generic Name | COBALT TELETHERAPY DEVICE |
| Baseline Model No | T780 |
| Baseline Catalog No | G22 |
| Baseline ID | * |
| Baseline Device Family | THERATRON |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-07-14 |