EIMAC-VARIAN S 90968 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-11-19 for EIMAC-VARIAN S 90968 NA manufactured by Elimac Varian (sold To: Fisher/machett).

Event Text Entries

[19489391] Pt was lying on the x-ray table having x-ray taken of her mandible. The extension cone was on the machine. A single ap film had been taken. The machine was being moved away from the pt to take another view. The machine was angled and the cone fell from the machine striking the pt's head. Cone installed wrong in 1990; side mount instead of front mount. No spring lock installed. Last inspection 5/29/96.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 51396
• MDR Report Key: 51396
• Date Received: 1996-11-19
• Date of Report: 1996-11-13
• Date of Event: 1996-11-11
• Date Facility Aware: 1996-11-11
• Report Date: 1996-11-13
• Date Reported to FDA: 1996-11-19
• Date Reported to Mfgr: 1996-11-19
• Date Added to Maude: 1996-11-27
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• 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: EIMAC-VARIAN
• Generic Name: BEAM LIMITING DEVICE
• Product Code: KPW
• Date Received: 1996-11-19
• Model Number: S 90968
• Catalog Number: NA
• Lot Number: NA
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: 6 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 52069
• Manufacturer: ELIMAC VARIAN (SOLD TO: FISHER/MACHETT)
• Manufacturer Address: 2301 WINDSOR CT ADDISON IL 60101 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1996-11-19