*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-01-18 for * manufactured by Fischer Imaging Corp.

Event Text Entries

[20768064] When testing equipment (no pt involved), the traumex drove all the way down and would not drive in an upward direction. A defective switch in the control handle was found. When defective switch was disabled, the unit worked properly. Concern is that the 'emergency cutt off' switch is located in a precarious position.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4002664
• MDR Report Key: 259537
• Date Received: 2000-01-18
• Date of Report: 1999-12-14
• Date of Event: 1999-11-05
• Date Added to Maude: 2000-01-27
• Event Key: 0
• Report Source Code: Voluntary 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: *
• Product Code: IYB
• Date Received: 2000-01-18
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 251341
• Manufacturer: FISCHER IMAGING CORP
• Manufacturer Address: 12300 NORTH GRANT ST DENVER CO * 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	1. Other	2000-01-18