TRAUMEX 80000GB *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2001-09-26 for TRAUMEX 80000GB * manufactured by Fischer Imaging Corp.

Event Text Entries

[231759] Chain broke and caused the assembly to fall down.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1418957-2001-00007
• MDR Report Key: 354282
• Report Source: 00
• Date Received: 2001-09-26
• Date of Report: 2001-09-20
• Date of Event: 2001-08-23
• Date Mfgr Received: 2001-08-30
• Device Manufacturer Date: 1991-10-01
• Date Added to Maude: 2001-10-04
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: BILL ABBOUD
• Manufacturer Street: 12300 N. GRANT DRIVE
• 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: OT
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TRAUMEX 80000GB
• Generic Name: *
• Product Code: IYB
• Date Received: 2001-09-26
• Model Number: 80000GB
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: OTHER
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 343502
• Manufacturer: FISCHER IMAGING CORP
• Manufacturer Address: 12300 N. GRANT ST DENVER CO 802413120 US
• Baseline Brand Name: TRAUMEX
• Baseline Generic Name: RAGIOGRAPHIC SYSTEM
• Baseline Model No: 80000GB
• Baseline Catalog No: NA
• Baseline ID: NA
• 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	2001-09-26