MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-06-29 for THERATRON 780 manufactured by Theratronics Intl. Ltd..
[6977]
The event involved a cobalt teletherapy machine. During use, the source began retracting before the preset time had elapsed. All the warning lights outside the room remained illuminated, indicating the source was in the "expose" position when it should have been in a shielded position. Rptr's conclusion was that the source was not fully retracting (source drawer failure), but was retracting far enough to adequately shield the source. The unit operated this way several times, but not every time. The mfr serviced the unit following the 4/27 episode, but it recurred 5/23. The unit has since been taken out of svc permanently.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1002646 |
| MDR Report Key | 12812 |
| Date Received | 1994-04-19 |
| Date of Report | 1994-06-03 |
| Date of Event | 1994-04-27 |
| Date Added to Maude | 1994-04-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERATRON |
| Generic Name | COBALT TELETHERAPY UNIT |
| Product Code | IWD |
| Date Received | 1994-06-29 |
| Model Number | 780 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 12811 |
| Manufacturer | THERATRONICS INTL. LTD. |
| Manufacturer Address | KANATA ONTARIO CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-04-19 |