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 1998-07-10 for THERATRON T780E G97 manufactured by Theratronics International Ltd.
[15489351]
It was reported that the gantry failed to stop rotating when the drive switch requesting the motion was released. The motion did stop when a second switch, the motion enable switch, was released. The head of the unit came to rest in contact with the treatment table. No patient injury or damage to the table was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610077-1998-00011 |
| MDR Report Key | 177376 |
| Report Source | 01,05,07 |
| Date Received | 1998-07-10 |
| Date of Report | 1998-07-10 |
| Date of Event | 1998-06-23 |
| Date Mfgr Received | 1998-06-23 |
| Device Manufacturer Date | 1997-06-01 |
| 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 | BIOMEDICAL ENGINEER |
| 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 THERAPY DEVICE |
| Product Code | IWD |
| Date Received | 1998-07-10 |
| Model Number | T780E |
| Catalog Number | G97 |
| 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 | 172475 |
| Manufacturer | THERATRONICS INTERNATIONAL LTD |
| Manufacturer Address | 413 MARCH ROAD PO BOX 13140 KANATA, ONTARIO CA K2K 2B7 |
| Baseline Brand Name | THERATON |
| Baseline Generic Name | COBALT THERAPY DEVICE |
| Baseline Model No | T780E |
| Baseline Catalog No | G97 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-07-10 |