EAGLE 4000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2008-08-13 for EAGLE 4000 manufactured by Ge Healthcare.

Event Text Entries

[885607] The customer alleged that their eagle monitor failed to alarm for asystole. No patient death or injury was reported. Ge healthcare's investigation into the reported occurrence is still ongoing. A follow-up report will be issued when the investigation has been completed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2124823-2008-00068
• MDR Report Key: 1111608
• Report Source: 06,07
• Date Received: 2008-08-13
• Date of Report: 2008-08-13
• Date of Event: 2008-07-15
• Date Mfgr Received: 2008-07-21
• Device Manufacturer Date: 1997-08-01
• Date Added to Maude: 2009-02-19
• 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: ANN LEBAR
• Manufacturer Street: 9900 INNOVATION DRIVE
• Manufacturer City: WAUWATOSA WI 53226
• Manufacturer Country: US
• Manufacturer Postal: 53226
• Manufacturer Phone: 4147213947
• Manufacturer G1: GE HEALTHCARE
• Manufacturer City: MILWAUKEE WI 53223
• Manufacturer Country: US
• Manufacturer Postal Code: 53223
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: EAGLE 4000
• Generic Name: PATIENT MONTIOR
• Product Code: LOS
• Date Received: 2008-08-13
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• 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		2008-08-13