TRAUMEX 1100-01-002 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-04-26 for TRAUMEX 1100-01-002 * manufactured by Fischer Imaging Corp..

Event Text Entries

[178971] Device 1: collimator will not stay in alignment to the film receptor. Device 2: after rotating collimator, collimator will not stay in alignment to the film receptor.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1018755
• MDR Report Key: 275289
• Date Received: 2000-04-26
• Date of Report: 2000-04-24
• Date of Event: 2000-04-13
• Date Added to Maude: 2000-04-28
• 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: BIOMEDICAL ENGINEER
• 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 Sequence Number: 1

• Brand Name: TRAUMEX
• Generic Name: MEDICAL IMAGING
• Product Code: IYB
• Date Received: 2000-04-26
• Model Number: 1100-01-002
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 266457
• Manufacturer: FISCHER IMAGING CORP.
• Manufacturer Address: 12300 N. GRANT ST. DENVER CO 802413120 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

Device Sequence Number: 2

• Brand Name: TRAUMEX
• Generic Name: COLLIMATOR
• Product Code: IYO
• Date Received: 2000-04-26
• Model Number: COLL-C-150
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 2
• Device Event Key: 266458
• Manufacturer: FISCHER IMAGING CORP.
• Manufacturer Address: 12300 N. GRANT ST. DENVER CO 802413120 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2000-04-26