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 1997-05-31 for THERATRON T1000 G90 manufactured by Theratronics Intl Ltd.
[54621]
While treating a pt on a cobalt 60 teletherapy device, electrical power to the machine was interrupted. When electrical power was restored, the equipment was restarted and the technician proceeded to deliver the balance of the treatment. Upon completion of the treatment, it became apparent that the treatment table had moved. The technologist checked the light field and discovered that the light field and hence the radiation field were not in the position set at the beginning of the treatment before electrical power was interrupted. The clinic estimated that 138 cgy was misdelivered over an area of apprx 21. 6 cm x 8. 6 cm to a depth of 0. 5 cm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610077-1997-00005 |
| MDR Report Key | 94811 |
| Report Source | 01,05,07 |
| Date Received | 1997-05-31 |
| Date of Report | 1997-05-28 |
| Date of Event | 1997-05-19 |
| Date Mfgr Received | 1997-05-21 |
| Date Added to Maude | 1997-06-03 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERATRON |
| Generic Name | COBALT THERAPY DEVICE |
| Product Code | IWD |
| Date Received | 1997-05-31 |
| Model Number | T1000 |
| Catalog Number | G90 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 | 93620 |
| Manufacturer | THERATRONICS INTL LTD |
| Manufacturer Address | 413 MARCH RD. P.O. BOX 6300 KANATA, ONTARIO CA K2K 2B7 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-05-31 |