*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-12-22 for * manufactured by Fischer Imaging Corp..

Event Text Entries

[19549776] 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 cut off" switch is located in a precarious position. Reported to mfr at time of event.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1017821
• MDR Report Key: 257032
• Date Received: 1999-12-22
• Date of Report: 1999-12-14
• Date of Event: 1999-11-05
• Date Added to Maude: 2000-01-04
• 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: ITY
• Date Received: 1999-12-22
• 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: 248906
• Manufacturer: FISCHER IMAGING CORP.
• Manufacturer Address: 12300 NORTH GRANT STREET DENVER CO 802413120 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-12-22