MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-05-02 for THERATRON CO-60 TELETHERAPY UNIT 780 manufactured by Theratronics Intl. Ltd..
[17826088]
On 3/31/93 there was a problem with the primary timer on the teletherapy unit. The timer, which terminates the radiation exposure by retracting the source, was not functioning properly as indicated by a back-up timing mechanism located at the console. The malfunctioning timer was not terminating the exposure at the preset time interval. The timer is directly responsible for ending the exposure, with failure potentially leading to pt misadministration. There were not any misadministrations or errors in pt doses due to the faulty timer. However, it created an unsafe situation that increased the chances of a pt misadministration. The timer has since been replaced and there have been no further complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1001787 |
| MDR Report Key | 13011 |
| Date Received | 1994-04-29 |
| Date of Report | 1994-04-20 |
| Date of Event | 1993-03-31 |
| Date Added to Maude | 1994-05-02 |
| 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 CO-60 TELETHERAPY UNIT |
| Generic Name | CO-60 TELETHERAPY UNIT |
| Product Code | IWD |
| Date Received | 1994-05-02 |
| Model Number | 780 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 13009 |
| Manufacturer | THERATRONICS INTL. LTD. |
| Manufacturer Address | KANATA ONTARIO * CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-04-29 |