MAUDE Adverse Event Report: CHANGE HEALTHCARE CANADA COMPANY CHANGE HEALTHCARE ENTERPRISE VIEWER

Model Number	2.1
Medical Device Problem Codes	Computer Software Problem (1112); Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Change healthcare investigated the reported issue and determined there was a software defect in change healthcare enterprise viewer (chev).The problem occurs when a scheduled study exists in a pacs patient record and a more recent performed study from the same patient record is opened in chev.Images from the opened (anchor) study are displayed in the viewport but the anchor study details and image thumbnails are not displayed on the patient timeline.The missing timeline information could potentially lead to a study context error.
Event or Problem Description
A neurosurgeon initially misinterpreted anchor images displayed in the viewport of the change healthcare enterprise viewer (chev) as a prior study.It was reported this caused the neurosurgeon to almost use the wrong image for surgery.No adverse consequences were reported.

• Brand Name: CHANGE HEALTHCARE ENTERPRISE VIEWER
• Common Device Name: ENTERPRISE VIEWER
• Manufacturer (Section D): CHANGE HEALTHCARE CANADA COMPANY; 10711 cambie road; richmond, british columbia V6X 3 G5; CA V6X 3G5
• MDR Report Key: 11488096
• Report Number: 8022257-2021-00001
• Device Sequence Number: 17001904
• Product Code: LLZ
• UDI-Device Identifier: 17540262010039
• UDI-Public: (01)17540262010039(10)020100
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K181185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2.1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1