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 |