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 1997-11-15 for THERATRON T1000 G90 manufactured by Theratronics Intl., Ltd..
[111569]
A service rep reported that the radioactive source failed to retract to the fully shielded position. The event occurred following installation of a replacement field light assembly and while the unit was undergoing tests prior to re-releasing the unit for clinical use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610077-1997-00013 |
| MDR Report Key | 133621 |
| Report Source | 01,05,07 |
| Date Received | 1997-11-15 |
| Date of Report | 1997-11-12 |
| Date of Event | 1997-10-19 |
| Date Facility Aware | 1997-10-19 |
| Date Mfgr Received | 1997-10-19 |
| Device Manufacturer Date | 1997-10-01 |
| Date Added to Maude | 1997-11-24 |
| 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 |
| Reporter Occupation | SERVICE PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | NO |
| 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 | 1997-11-15 |
| Model Number | T1000 |
| Catalog Number | G90 |
| Lot Number | NA |
| ID Number | NA |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 130590 |
| Manufacturer | THERATRONICS INTL., LTD. |
| Manufacturer Address | 413 MARCH RD. P.O. BOX 13140 KANATA, ONTARIO * K2K 2B7 |
| Baseline Brand Name | THERATRON |
| Baseline Generic Name | COBALT TELETHERAPY DEVICE |
| Baseline Model No | T1000 |
| Baseline Catalog No | G90 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-11-15 |