MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 1996-11-07 for THERATRON T80 G10 manufactured by Theratronics International Limited.
[37809]
After the termination of a treatment the source did not retract to the fully shielded position. The pt was removed from the treatment room and another pt brought in. During treatment setup it was observed that there was no light field. The pt was left on the treatment table while the operator went to get the technical support tech. The source indicator rod was exposed indicating that the source was in the fully exposed position. The operator removed the pt from the treatment room. Fifteen minutes elapsed before it was identified that the source position indicator rod was exposed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610077-1996-00001 |
| MDR Report Key | 53858 |
| Report Source | 01,05 |
| Date Received | 1996-11-07 |
| Date of Report | 1996-11-07 |
| Date of Event | 1996-10-14 |
| Date Mfgr Received | 1996-10-21 |
| Device Manufacturer Date | 1982-12-01 |
| Date Added to Maude | 1996-12-09 |
| 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 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERATRON |
| Generic Name | COBALT TELETHERAPY DEVICE |
| Product Code | IWD |
| Date Received | 1996-11-07 |
| Model Number | T80 |
| Catalog Number | G10 |
| 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 | 54446 |
| Manufacturer | THERATRONICS INTERNATIONAL LIMITED |
| Manufacturer Address | P.O. BOX 13140 413 MARCH RD KANATA ONTARIO CA K2K2B7 |
| Baseline Brand Name | THERATRON |
| Baseline Generic Name | COBALT TELETHERAPY DEVICE |
| Baseline Model No | T80 |
| Baseline Catalog No | G10 |
| 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 | 1996-11-07 |