MAUDE Adverse Event Report: EPIC SYSTEMS CORP. EPIC EMR; BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Confusion/ Disorientation (2553)

Event Date 04/01/2022

Event Type  Injury  

Event Description

Order placed in epic software, but lab could not see it, no order resulted.Csf could not be done as too much time elapsed.Other labs were dubious.Resulted in prolonged hospitalization, exposure to longer abx, confusion.Fda safety report id # (b)(4).

• Brand Name: EPIC EMR
• Type of Device: BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
• Manufacturer (Section D): EPIC SYSTEMS CORP.
• MDR Report Key: 14043665
• MDR Text Key: 288875264
• Report Number: MW5108816
• Device Sequence Number: 1
• Product Code: MMH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White