MAUDE Adverse Event Report: ALLSCRIPTS SUNRISE; EHR/MDDS

Device Problem Patient Data Problem (3197)

Patient Problem No Information (3190)

Event Date 07/07/2014

Event Type  Injury  

Event Description

One day after admission to an acute care hospital for treatment of sepsis and endocarditis, the pt informed staff that she was being stalked and wanted to be identified by an alias.A new name was entered, registered, and established for her ehr and mdds.However, the digital records of the first day in the hospital under her real name were no longer accessible.When the name entered on the ehr on admission was searched, the name entered to the alias, and the records and data in the mdds appeared but started on day two.Inaccessible were the records and data in the ehr and mdds from day one, compromising care and understanding of the case.Ehr systems have failed this pt, and fail to enable flexibility in identifying pts in unique circumstances.

• Brand Name: SUNRISE
• Type of Device: EHR/MDDS
• Manufacturer (Section D): ALLSCRIPTS; raleigh NC 27615
• MDR Report Key: 3955738
• MDR Text Key: 4561191
• Report Number: MW5037370
• Device Sequence Number: 1
• Product Code: LNX
• 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: 07/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 40 YR
• Patient Weight: 74