EAGLE 4000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-04-18 for EAGLE 4000 manufactured by Ge Healthcare.

Event Text Entries

[2602184] It was reported that there was no audio on the eagle 4000 patient monitor due to a hardware failure. There was no death or serious injury associated with this event, nor was medical intervention required. Ge healthcare's investigation is ongoing. A follow up report will be submitted once the investigation has been completed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2124823-2012-00051
• MDR Report Key: 2544924
• Report Source: 06
• Date Received: 2012-04-18
• Date of Report: 2012-03-20
• Date of Event: 2012-03-20
• Date Mfgr Received: 2012-03-20
• Device Manufacturer Date: 2005-02-01
• Date Added to Maude: 2012-09-12
• 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: 3
• Reporter Occupation: BIOMEDICAL ENGINEER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: JOY SONSALLA
• Manufacturer Street: 3000 N. GRANDVIEW BLVD. W450
• Manufacturer City: WAUKESHA WI 53188
• Manufacturer Country: US
• Manufacturer Postal: 53188
• Manufacturer Phone: 2625482661
• Manufacturer G1: GE HEALTHCARE
• Manufacturer City: MILWAUKEE WI
• Manufacturer Country: US
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: EAGLE 4000
• Generic Name: PHYSIOLOGICAL PATIENT MONITOR
• Product Code: LOS
• Date Received: 2012-04-18
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GE HEALTHCARE
• Manufacturer Address: MILWAUKEE WI US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-04-18