TRAUMEX 1100-01-002 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-01-18 for TRAUMEX 1100-01-002 * manufactured by Fischer Imaging Corporation.

Event Text Entries

[17171834] When testing equipment (no pt involved) the traumex drove all the way down and would not drive in an upward direction. When the defective switch was disabled the unit worked properly.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1418957-2000-00001
• MDR Report Key: 259539
• Report Source: 05
• Date Received: 2000-01-18
• Date of Event: 1999-10-05
• Date Mfgr Received: 1999-12-17
• Device Manufacturer Date: 1989-08-01
• Date Added to Maude: 2000-01-27
• 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
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: JANET PRIEUR
• Manufacturer Street: 12300 N. GRANT ST.
• Manufacturer City: DENVER CO 80241
• Manufacturer Country: US
• Manufacturer Postal: 80241
• Manufacturer Phone: 3034526800
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: NO
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TRAUMEX
• Generic Name: RADIOGRAPHIC SYSTEM
• Product Code: IYB
• Date Received: 2000-01-18
• Model Number: 1100-01-002
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 251341
• Manufacturer: FISCHER IMAGING CORPORATION
• Manufacturer Address: 12300 N. GRANT DRIVE DENVER CO 80241 US
• Baseline Brand Name: TRAUMEX
• Baseline Generic Name: RADIOGRAPHIC SYSTEM
• Baseline Model No: 1100-01-002
• Baseline Catalog No: NA
• Baseline ID: DX TRAUMEX
• Baseline Device Family: TRAUMEX
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K880530
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0		2000-01-18