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 1998-06-30 for THERATRON T1000E G98 manufactured by *.
[100286]
It was reported that both the gantry and table will rotate by themselves without anyone touching the switches on the hand control.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610077-1998-00009 |
| MDR Report Key | 177328 |
| Report Source | 01,05,07 |
| Date Received | 1998-06-30 |
| Date of Report | 1998-05-25 |
| Date of Event | 1998-04-26 |
| Date Mfgr Received | 1998-04-28 |
| Device Manufacturer Date | 1998-02-01 |
| Date Added to Maude | 1998-07-17 |
| 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 |
| 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 | 1998-06-30 |
| Model Number | T1000E |
| Catalog Number | G98 |
| 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 | 172430 |
| Manufacturer | * |
| Manufacturer Address | 413 MARCH RD. P.O BOX 13140 KANATA, ONTARIO CA K2K 2B7 |
| Baseline Brand Name | THERATRON |
| Baseline Generic Name | COBALT TELETHEREAPY DEVICE |
| Baseline Model No | T1000E |
| Baseline Catalog No | G98 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-06-30 |