MAUDE Adverse Event Report: 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	01/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that when viewing studies in change healthcare enterprise viewer (chev), it did not retain the presentation state for the same study saved in pacs.There was no patient harm reported as a result of this issue.The investigation concluded that while this issue was the result of a malfunction, it was not likely to result in a reportable adverse event or serious injury.Further investigations determined this is caused by a software defect that when imaging studies are viewed in chev version 2.1, the studies do not retain the image styles defined by presentation states created and saved in change healthcare radiology solutions (chrs).Image styles include the following attributes of image display: orientation, window/level, and roi (zoom/pan).Change healthcare will be notifying affected customers of this issue and providing a software patch to correct the issue.
Event or Problem Description
The customer reported that when viewing studies in chev, they did not retain the presentation state from the same study in pacs.There was no patient harm reported as a result of this issue.

• Brand Name: CHANGE HEALTHCARE ENTERPRISE VIEWER
• Common Device Name: ENTERPRISE VIEWER
• MDR Report Key: 11689299
• Report Number: 8022257-2021-00002
• Device Sequence Number: 11545372
• 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: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 04/19/2021

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): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 04/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1