FISCHER IMAGING CORP 8018964T *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-31 for FISCHER IMAGING CORP 8018964T * manufactured by Fischer Imaging Corp.

Event Text Entries

[20889975] While x-ray technologist was positioning fischer traumex iii machine from horizontal to vertical position, c-arm bucky and tube assemby fell suddenly injuring the technologist.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 141135
• MDR Report Key: 141135
• Date Received: 1997-12-31
• Date of Report: 1997-12-10
• Date of Event: 1997-11-29
• Date Facility Aware: 1997-12-01
• Report Date: 1997-12-10
• Date Reported to FDA: 1997-12-12
• Date Reported to Mfgr: 1997-12-12
• Date Added to Maude: 1998-01-05
• 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
• 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: FISCHER IMAGING CORP
• Generic Name: FISCHER TRAUMEX III
• Product Code: ITY
• Date Received: 1997-12-31
• Model Number: 8018964T
• Catalog Number: *
• Lot Number: NA
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 3 YR
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 137755
• Manufacturer: FISCHER IMAGING CORP
• Manufacturer Address: 12300 NORTH GRANT ST DENVER CO 80241 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	1997-12-31