RAD 60 X-RAY TUBE 89150 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-15 for RAD 60 X-RAY TUBE 89150 * manufactured by Varian Associates Inc..

Event Text Entries

[89228] During a fluoro procedure, hot oil dripped on pt causing third-degree burns. Case was stopped immediately. (dist narrative) varian's x-ray tube is interfaced into the liebel-flarsheim's hydraview plus urology sys. An lf svc rep went to hosp on 12/9/97 and found the bellows of the x-ray tube ruptured. The x-ray tube was replaced and the generator recalibrated. The hosp kept the x-ray tube. Neither the submission of this or other information to the fda pursuant to 21 cfr 803 nor public release of such information constitutes an admission that this device is defective or establishes the existence of any causual connection between this device and a death or serious injury.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1518293-1997-00012
• MDR Report Key: 138283
• Date Received: 1997-12-15
• Date of Report: 1997-12-15
• Date of Event: 1997-12-09
• Date Facility Aware: 1997-12-09
• Report Date: 1997-12-15
• Date Reported to FDA: 1997-12-15
• Date Reported to Mfgr: 1997-12-15
• Date Added to Maude: 1997-12-18
• Event Key: 0
• Report Source Code: Distributor 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: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: RAD 60 X-RAY TUBE
• Generic Name: X-RAY TUBE
• Product Code: ITY
• Date Received: 1997-12-15
• Model Number: 89150
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: 10 MO
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 135045
• Manufacturer: VARIAN ASSOCIATES INC.
• Manufacturer Address: 600 WEST UNIVERSITY DR. ARLINGTON HEIGHTS IL 60004 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1997-12-15