MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-10-15 for VARIAN A292/B150 * manufactured by Varian Interay.
[116890]
A seal ruptured on an x-ray tube assembly, allowing oil to spill onto the pt. The extent of injury is unk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1035768-1998-00001 |
| MDR Report Key | 191739 |
| Report Source | 06 |
| Date Received | 1998-10-15 |
| Date of Report | 1998-10-14 |
| Date of Event | 1998-10-14 |
| Date Mfgr Received | 1998-10-14 |
| Device Manufacturer Date | 1995-09-01 |
| Date Added to Maude | 1998-10-16 |
| 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 | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VARIAN A292/B150 |
| Generic Name | DIAGNOSTIC X-RAY TUBE HSG. ASSMB |
| Product Code | ITY |
| Date Received | 1998-10-15 |
| Model Number | A292/B150 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 186317 |
| Manufacturer | VARIAN INTERAY |
| Manufacturer Address | 3235 FORTUNE DR. CHARLESTON SC 29418 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-10-15 |