EAGLE 4000 PATIENT MONITOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-06-15 for EAGLE 4000 PATIENT MONITOR manufactured by Ge Healthcare.

Event Text Entries

[2136897] It was reported that an asystole event occurred without an audible alarm at the eagle 4000 bedside monitor or the clinical information center (cic). A visual asystole alarm was displayed at the bedside monitor and at the cic. The cic log files show that vfib-vtach alarms were provided at 50% volume and that alarms were silenced numerous times at the bedside and at the cic. No ecg strips are available. There was no reported patient injury associated with this event. 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


[9252905] The device manufacture date is unknown.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2124823-2011-00097
MDR Report Key2175228
Report Source01,05,06
Date Received2011-06-15
Date of Report2011-06-15
Date of Event2011-05-16
Date Mfgr Received2011-05-17
Date Added to Maude2011-08-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactJOY SONSALLA
Manufacturer Street3000 N. GRANDVIEW BLVD. W450
Manufacturer CityWAUKESHA WI 53188
Manufacturer CountryUS
Manufacturer Postal53188
Manufacturer Phone2625482661
Manufacturer G1GE HEALTHCARE
Manufacturer CityMILWAUKEE WI
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEAGLE 4000 PATIENT MONITOR
Generic NamePATIENT MONITORING SYSTEM
Product CodeLOS
Date Received2011-06-15
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerGE HEALTHCARE
Manufacturer AddressMILWAUKEE WI US


Patients

Patient NumberTreatmentOutcomeDate
10 2011-06-15

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