MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-04-17 for PRIMUS ACCELERATOR * manufactured by Siemens Medical.
[599290]
A patient treatment with the siemens primus linear accelerator was initiated in 6mv photon mode. The accelerator "beeped" continuously as if it was producing radiation, but no radiation monitor units were indicated on either the primary or secondary indicator. After approximately 10 seconds, the machine terminated with a "communication error. " if the machine was producing radiation, the pt rec'd an estimated 42 cgy of excess radiation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1042630 |
| MDR Report Key | 840619 |
| Date Received | 2007-04-17 |
| Date of Report | 2007-04-17 |
| Date of Event | 2007-02-06 |
| Date Added to Maude | 2007-04-25 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRIMUS ACCELERATOR |
| Generic Name | * |
| Product Code | IYX |
| Date Received | 2007-04-17 |
| Returned To Mfg | 2007-02-15 |
| Model Number | PRIMUS |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 827904 |
| Manufacturer | SIEMENS MEDICAL |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-17 |