NAUTILUS TOCO TRANSDUCER 2264LAX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2002-06-26 for NAUTILUS TOCO TRANSDUCER 2264LAX manufactured by General Electric Medical Systems Information Technologies.

Event Text Entries

[277111] Customer claims issues with frequent baseline drift giving inaccurate readings and accessories not functional.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2124823-2002-00002
• MDR Report Key: 404524
• Report Source: 00,06
• Date Received: 2002-06-26
• Date of Report: 2002-01-04
• Date of Event: 2001-08-21
• Date Mfgr Received: 2002-01-18
• Date Added to Maude: 2002-07-16
• 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: ANNIE BODE
• Manufacturer Street: 8200 W TOWER AVE
• Manufacturer City: MILWAUKEE WI 53223
• Manufacturer Country: US
• Manufacturer Postal: 53223
• Manufacturer Phone: 4143622368
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NAUTILUS TOCO TRANSDUCER
• Generic Name: FETAL MONITOR ACCESSORY
• Product Code: HEL
• Date Received: 2002-06-26
• Model Number: NAUTILUS
• Catalog Number: 2264LAX
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 393520
• Manufacturer: GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
• Manufacturer Address: 8200 WEST TOWER AVE. MILWAUKEE WI 53223 US
• Baseline Brand Name: NAUTILUS TOCO TRANSDUCER
• Baseline Generic Name: FETAL MONITOR ACCESSORY
• Baseline Model No: NAUTILUS
• Baseline Catalog No: 2264LAX
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0		2002-06-26