FT-41 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2001-10-08 for FT-41 * manufactured by Ge Medicor.

Event Text Entries

[231907] The tubestand counterpoise lost its strength and the tube assembly slid down to its lowest position.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1528327-2001-00001
• MDR Report Key: 355529
• Report Source: 08
• Date Received: 2001-10-08
• Date of Report: 2001-10-05
• Date Mfgr Received: 2001-08-30
• Device Manufacturer Date: 1998-01-01
• Date Added to Maude: 2001-10-15
• 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 Street: 2289 WESTBROOKE DRIVE
• Manufacturer City: COLUMBUS OH 43228
• Manufacturer Country: US
• Manufacturer Postal: 43228
• Manufacturer Phone: 6147779729
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: FT-41
• Generic Name: OVERHEAD TUBE CRANE
• Product Code: IYB
• Date Received: 2001-10-08
• Returned To Mfg: 2001-09-25
• Model Number: FT-41
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 344748
• Manufacturer: GE MEDICOR
• Manufacturer Address: * * US
• Baseline Brand Name: FT-41
• Baseline Generic Name: OVERHEAD TUBE CRANE
• Baseline Model No: FT-41
• Baseline Catalog No: *
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2001-10-08