EPIC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-13 for EPIC manufactured by Epic Systems Corporation.

MAUDE Entry Details

Report NumberMW5089001
MDR Report Key8892993
Date Received2019-08-13
Date of Report2019-08-13
Date Added to Maude2019-08-14
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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 FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameEPIC
Generic NameBLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
Product CodeMMH
Date Received2019-08-13
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerEPIC SYSTEMS CORPORATION


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-13

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